Drug Information

View drug alerts Information in California or New York
 
The Drug Information Center has a wealth of information to help you understand how drugs impact your health as well as their place in today's healthcare environment. 
 
The information you'll find in the center covers a number of important topics ranging from drug safety and side effects to medication costs and errors. You'll also notice from time to time we will display drug alerts. These alerts will let you know when a New Drug is put on the market, if a drug has been recalled, and if a drug has a new indication or use. 
 
 
Drug Name Drug Reason Date
Darzalex
The Food and Drug Administration (FDA) approved Darzalex® (daratumumab injection) in combination with bortezomib, thalidomide and dexamethasone (VTd) as treatment for individuals newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant (ASCT). Source: FDA website
Expanded Indication 09-26-19
Dysport
The Food and Drug Administration (FDA) approved Dysport® (abobotulinumtoxinA injection) to include the treatment of upper limb spasticity in individuals aged 2 years and older, excluding spasticity caused by cerebral palsy. Source: FDA website
Expanded Indication 09-26-19
Mavyret
The Food and Drug Administration (FDA) approved Mavyret® (glecaprevir/pibrentasvir tablets) for an eight-week duration for the treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment-naïve). Source: FDA website
Expanded Indication 09-26-19
Rituxan
The Food and Drug Administration (FDA) approved Rituxan® (rituximab injection) to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children 2 years of age and older in combination with glucocorticoids. Source: FDA website
Expanded Indication 09-27-19
Crysvita
The Food and Drug Administration (FDA) approved Crysvita® (burosumab injection) to include treatment in pediatric individuals as young as 6 months with X-linked hypophosphatemia (XLH). Source: FDA website
Expanded Indication 10-01-19
Invokana
The Food and Drug Administration (FDA) approved Invokana® (canagliflozin tablets) to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes and diabetic kidney disease (nephropathy) with a certain amount of protein in the urine. Source: FDA website
New Indication 09-27-19
Jynneos
The Food and Drug Administration (FDA) approved Jynneos® (smallpox and monkeypox vaccine, live, non-replicating injection) for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. Source: FDA website
New Vaccine 09-24-19
Apotex
Apotex announced a voluntary recall of ranitidine tablets, brand and generic formulations, due to the potential for detection of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-ranitidine-tablets-75mg-and-150mg-all-pack-sizes-and Source: FDA website
Drug Recall 09-27-19
Sandoz
Sandoz announced a voluntary recall of ranitidine capsules due to the potential for detection of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg-due-elevated Source: FDA website
Drug Recall 09-24-19
Taltz
The Food and Drug Administration (FDA) approved Taltz® (ixekizumab injection) for the treatment of adults with active ankylosing spondylitis. Source: FDA website
New Indication 08-23-19
Nourianz
The Food and Drug Administration (FDA) approved NourianzTM (istradefylline tablets) as an add-on treatment to levodopa/carbidopa in adults with Parkinson's disease (PD) experiencing "off" episodes. Source: FDA website
New Drug 08-27-19
Rinvoq
The Food and Drug Administration (FDA) approved RinvoqTM (upadacitinib tablets) for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. Source: FDA website
New Drug 08-16-19
Xenleta
The Food and Drug Administration (FDA) approved XenletaTM (lefamulin tablets and injection) for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria. Source: FDA website
New Drug 08-19-19
AmEx Pharmacy
The Food and Drug Administration (FDA) is reminding consumers and healthcare providers not to use drug products intended to be sterile made by Pacifico National Inc., an outsourcing facility doing business as AmEx Pharmacy in Melbourne, Florida due to quality and sterility concerns. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/news-events/press-announcements/fda-requests-recall-sterile-compounded-drug-products-produced-pacifico-national-inc-dba-amex Source: FDA website
Drug Warning 08-27-19
Hepatitis C medications
The Food and Drug Administration (FDA) has received reports that the use of MavyretTM (glecaprevir/pibrentasvir tablets), Zepatier® (elbasvir/grazoprevir tablets), or Vosevi® (sofosbuvir/velpatasvir tablets) to treat chronic Hepatitis C in individuals with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/hepatitis-c-medicines-mavyret-zepatier-and-vosevi-drug-safety-communication-due-rare-occurrence-0 Source: FDA website
Drug Warning 08-28-19
Clenpiq
The Food and Drug Administration (FDA) approved Clenpiq® (sodium picosulfate/magnesium oxide/anhydrous citric acid oral solution) to include use in pediatric individuals 9 years of age and older for cleansing of the colon as a preparation for colonoscopy. Source: FDA website
Expanded Indication 08-12-19
Sirturo
The Food and Drug Administration (FDA) approved Sirturo® (bedaquiline tablets) use in pediatric individuals aged 12 to less than 18 years and weighing at least 30 kg as part of combination therapy for pulmonary multidrug-resistant tuberculosis (MDR-TB), when an effective treatment regimen cannot otherwise be provided. Source: FDA website
New Indication 08-12-19
Dulera
The Food and Drug Administration (FDA) approved Dulera® (mometasone furoate/formoterol fumarate oral inhaler) for asthma in pediatric individuals 5 years of age and older. Source: FDA website
Expanded Indication 08-14-19
Asmanex HFA
The Food and Drug Administration (FDA) approved Asmanex® HFA (mometasone furoate oral inhaler) for asthma in pediatric individuals 5 years of age and older. Source: FDA website
Expanded Indication 08-14-19
Eylea
The Food and Drug Administration (FDA) approved Eylea® (aflibercept pre-filled injection) for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy. Source: FDA website
New Formulation 08-13-19
Pretomanid
The Food and Drug Administration (FDA) approved Pretomanid tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs. Source: FDA website
New Drug 08-14-19
Wakix
The Food and Drug Administration (FDA) approved Wakix® (pitolisant tablets) for the treatment of excessive daytime sleepiness (EDS) in adults with narcolepsy. Source: FDA website
New Drug 08-14-19
Rozlytrek
The Food and Drug Administration (FDA) approved RozlytrekTM (entrectinib capsules) for the treatment of adult and adolescent individuals whose cancers have the specific genetic defect neurotrophic tyrosine receptor kinase (NTRK) gene fusion and for whom there are no effective treatments. It is also indicated for the treatment of adults with non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive and have spread to other parts of the body. Source: FDA website
New Drug 08-15-19
Inrebic
The Food and Drug Administration (FDA) approved Inrebic® (fedratinib capsules) for the treatment of adults with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). Source: FDA website
New Drug 08-16-19
Relpax
Pfizer announced a voluntary recall of 2 lots of Relpax 40 mg tablets due to potential microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-inc-issues-voluntary-nationwide-recall-2-lots-relpaxr-eletriptan-hydrobromide-40-mg-tablets Source: FDA website
Drug Recall 08-15-19
Entacapone
The Food and Drug Administration (FDA) announced they found no increased risk of prostate cancer with Parkinson’s disease medications, Comtan (entacapone) and Stalevo (entacapone/carbidopa/levodopa). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-review-finds-no-increased-risk-prostate-cancer-parkinsons-disease-medicines-containing Source: FDA website
Drug Warning 08-13-19
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of individuals with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express programmed death-ligand 1 PD-L1 (combined positive score ≥10) as determined by a Food and Drug Administration (FDA)-approved test, with disease progression after 1 or more prior lines of systemic therapy. Source: FDA website
New Indication 07-19-19
Enstilar
The Food and Drug Administration (FDA) approved Enstilar® Foam (calcipotriene/betamethasone dipropionate topical foam) for the treatment of plaque psoriais in individuals 12 years and older. Source: FDA website
Expanded Indication 08-01-19
Taclonex
The Food and Drug Administration (FDA) approved Taclonex® Topical Suspension (calcipotriene/betamethasone dipropionate topical suspension) for the treatment of plaque psoriais in individuals 12 years and older. Source: FDA website
Expanded Indication 08-01-19
Baqsimi
The Food and Drug Administration (FDA) approved BaqsimiTM (glucagon nasal powder) for the treatment of severe hypoglycemia in individuals with diabetes 4 years of age and older. Source: FDA website
New Formulation 07-24-19
Angiomax RTU
The Food and Drug Administration (FDA) approved Angiomax RTU (bivalirudin injection) for use as an anticoagulant in individuals undergoing percutaneous coronary intervention (PCI), including those with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. Source: FDA website
New Formulation 07-25-19
Accrufer
The Food and Drug Administration (FDA) approved AccruferTM (ferric maltol capsules) for the treatment of iron deficiency in adults. Source: FDA website
New Drug 07-25-19
Nubeqa
The Food and Drug Administration (FDA) approved NubeqaTM (darolutamide tablets) for the treatment of men with non-metastatic castration-resistant prostate cancer. Source: FDA website
New Drug 07-30-19
Turalio
The Food and Drug Administration (FDA) approved TuralioTM (pexidartinib capsules) for the treatment of adults with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe disease or functional limitations, and cannot be improved with surgery, Source: FDA website
New Drug 08-02-19
Jubilant Cadista Pharmaceuticals
Jubilant Cadista Pharmaceuticals announced a voluntary recall of one lot of drospirenone and ethinyl estradiol tablets due to out-of-specification dissolution results that could affect efficacy. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jubilant-cadista-pharmaceuticals-inc-issues-voluntary-nationwide-recall-drospirenone-and-ethinyl Source: FDA website
Drug Recall 07-24-19
Ridge Properties
Ridge Properties announced a voluntary recall of 4 lots of 4% lidocaine topical cream and liquid gel products due to microbiological contamination and higher than labeled potency. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ridge-properties-llc-dba-pain-relief-naturally-issues-voluntary-nationwide-recall-pre-tat-superior-0 Source: FDA website
Drug Recall 08-09-19
Xeljanz; Xeljanz XR
The Food and Drug Administration (FDA) approved new warnings about an increased risk of blood clots and death with the 10 mg twice daily dose of Xeljanz® and Xeljanz XR® (tofacitinib tablets and tofacitinib extended-release tablets), which are used in individuals with ulcerative colitis. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/xeljanz-xeljanz-xr-tofacitinib-drug-safety-communication-due-increased-risk-blood-clots-and-death Source: FDA website
Drug Warning 07-26-19
Otezla
The Food and Drug Administration (FDA) approved Otezla® (apremilast tablets) for the treatment of oral ulcers in adults with Behcet's disease. Source: FDA website
New Indication 07-19-19
Drizalma Sprinkle
The Food and Drug Administration (FDA) approved Drizalma SprinkleTM (duloxetine delayed-release capsules) for the treatment of chronic musculoskeletal pain, generalized anxiety disorder, major depressive disorder, and pain associated with diabetic peripheral neuropathy. Source: FDA website
New Formulation 07-19-19
Zinc sulfate
The Food and Drug Administration (FDA) approved Zinc sulfate injection in adult and pediatric individuals as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Source: FDA website
New Formulation 07-18-19
Altaire Pharmaceuticals
Altaire Pharmaceuticals announced a voluntary recall of all prescription and over-the-counter (OTC) drug products and lots, within expiry, sold by OCuSOFT during specific time period due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-ophthalmic-products-sold-ocusoft Source: FDA website
Drug Recall 07-16-19
Altaire Pharmaceuticals
Altaire Pharmaceuticals announced a voluntary recall of all over-the-counter (OTC) drug products and lots, within expiry, sold by Natural Ophthalmics and TRP Company, Inc. during specific time period due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-over-counter-ophthalmic-products-sold-natural Source: FDA website
Drug Recall 07-16-19
Altaire Pharmaceuticals
Altaire Pharmaceuticals announced a voluntary recall of all over-the-counter (OTC) drug products and lots, within expiry, sold by Accutome, Focus Laboratories, Grandall Distributing Co., and Prestige Brands during specific time period due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-over-counter-ophthalmic-products-sold Source: FDA website
Drug Recall 07-16-19
Kogenate FS Antihemophilic Factor
Bayer announced a voluntary recall of two lots of labeled Kogenate® FS antihemophilic factor (recombinant injection) 2000 IU vials due to these lots actually containing Jivi antihemophilic factor. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayer-statement-voluntary-recall-two-lots-kogenater-fs-antihemophilic-factor-recombinant-united Source: FDA website
Drug Recall 07-22-19
Xembify
The Food and Drug Administration (FDA) approved Xembify® (immune globulin subcutaneous, human injection) for the treatment of primary humoral immunodeficiency (PI) in individuals 2 years of age and older. Source: FDA website
New Formulation 07-03-19
Katerzia
The Food and Drug Administration (FDA) approved KaterziaTM (amlodipine benzoate oral suspension) for the treatment of hypertension (high blood pressure) in adults and pediatric individuals 6 years of age and older and coronary artery disease in adults. Source: FDA website
New Formulation 07-08-19
AirDuo Digihaler
The Food and Drug Administration (FDA) approved AirDuo® DigihalerTM (fluticasone propionate/salmeterol oral inhalation) with built-in electronic module, approved for the treatment of asthma in individuals aged 12 years and older. Source: FDA website
New Formulation 07-15-19
Recarbrio
The Food and Drug Administration (FDA) approved RecarbrioTM (imipenem/cilastatin/relebactam injection) to treat adults with complicated urinary tract infections (cUTIs) and complicated intra-abdominal infections (cIAIs). Source: FDA website
New Drug 07-17-19
Altaire Pharmaceuticals
Altaire Pharmaceuticals announced another voluntary recall of all over the counter (OTC) and prescription drug ophthalmic products and lots, within expiry, during specific time periods due to lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-ophthalmic-products-manufactured-and Source: FDA website
Drug Recall 07-15-19
Altaire Pharmaceuticals
Altaire Pharmaceuticals announced a voluntary recall of all drug products and lots, within expiry, sold at Walgreens during a specified time period due to concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-ophthalmic-products-sold-walgreens Source: FDA website
Drug Recall 07-03-19
Altaire Pharmaceuticals
Altaire Pharmaceuticals announced a voluntary recall of all drug products and lots, within expiry, sold at CVS during a specified time period due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-ophthalmic-products-sold-cvs Source: FDA website
Drug Recall 07-10-19
Thiola EC
The Food and Drug Administration (FDA) approved Thiola® EC (tiopronin enteric-coated tablets) for the treatment of cystinuria. Source: FDA website
New Formulation 06-28-19
Xpovio
The Food and Drug Administration (FDA) approved XpovioTM (selinexor tablets) indicated in combination with dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti‐CD38 monoclonal antibody. Source: FDA website
New Drug 07-03-19
Fresenius Kabi
Fresenius Kabi announced a voluntary recall of 2 lots of fluorouracil injection due to the potential for glass particulate. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-two-lots-fluorouracil-injection-due-potential Source: FDA website
Drug Recall 07-02-19
PharMEDium Services
PharMEDium Services announced a voluntary recall of 45 lots of hydromorphone injection due to their electronic customer ordering system stating the products are sulfite-free when they do contain sulfite. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pharmedium-services-llc-issues-voluntary-nationwide-recall-05-mgml-hydromorphone-hcl-09-sodium Source: FDA website
Drug Recall 06-28-19
Altaire Pharmaceuticals
Altaire Pharmaceuticals announced a voluntary recall of all drug products and lots within expiry distributed during specific time periods due to possible sterility issues. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-ophthalmic-products Source: FDA website
Drug Recall 07-03-19
Pacifico National
The Food and Drug Administration (FDA) is warning consumers and healthcare providers not to use products intended to be sterile produced by Pacifico National, doing business as AmEx Pharmacy, due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-patients-and-health-care-professionals-not-use-sterile-products-pacifico-national-inc-dba Source: FDA website
Drug Warning 06-28-19
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) as monotherapy for the treatment of individuals with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. Source: FDA website
New Indication 06-18-19
Livalo
The Food and Drug Administration (FDA) approved Livalo® (pitavastatin tablets) for use in pediatric individuals aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B (ApoB). Source: FDA website
New Indication 06-18-19
Biktarvy
The Food and Drug Administration (FDA) approved Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide tablets) to include treatment of both adult and pediatric individuals weighing at least 25 kg with human immunodeficiency virus (HIV)-1 who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. Source: FDA website
New Indication 06-19-19
Dextenza
The Food and Drug Administration (FDA) approved Dextenza® (dexamethasone ocular insert) for the treatment of ocular inflammation following ophthalmic surgery. Source: FDA website
New Indication 06-21-19
Botox
The Food and Drug Administration (FDA) approved Botox® (onabotulinumtoxinA injection) for the treatment of upper limb spasticity in pediatric individuals 2-17 years of age. Source: FDA website
New Indication 06-21-19
Symdeko
The Food and Drug Administration (FDA) approved Symdeko® (tezacaftor/ivacaftor tablets) for the treatment of pediatric individuals ages 6 years and older with cystic fibrosis who have certain genetic mutations. Source: FDA website
New Indication 06-21-19
Dupixent
The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) to treat adults with nasal polyps (growths on the inner lining of the sinuses) accompanied by chronic rhinosinusitis (prolonged inflammation of the sinuses and nasal cavity). Source: FDA website
New Indication 06-26-19
Doptelet
The Food and Drug Administration (FDA) approved Doptelet® (avatrombopag tablets) to include the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Source: FDA website
New Indication 06-27-19
Soliris
The Food and Drug Administration (FDA) approved Soliris® (eculizumab injection) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Source: FDA website
New Indication 06-27-19
Darzalex
The Food and Drug Administration (FDA) approved Darzalex® (daratumumab injection) in combination with lenalidomide and dexamethasone for individuals with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. Source: FDA website Source: FDA website
New Indication 06-27-19
Myxredlin
The Food and Drug Administration (FDA) approved Myxredlin (human insulin in sodium chloride injection) to improve glycemic control in adults and pediatric individuals with diabetes mellitus. Source: FDA website
New Formulation 06-20-19
Vyleesi
The Food and Drug Administration (FDA) approved VyleesiTM (bremelanotide injection) for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). Source: FDA website
New Drug 06-21-19
Macleods
Macleods Pharmaceuticals announced a voluntary recall of 32 lots of losartan potassium tablets and losartan potassium/hydrochlorothiazide tablets due to detection of trace amounts of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/macleods-pharmaceutical-limited-issues-voluntary-nationwide-consumer-level-recall-losartan-potassium Source: FDA website
Drug Recall 06-26-19
Premier Pharmacy Labs
Premier Pharmacy Labs announced a voluntary recall of all unexpired products, intended to be sterile, due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/premier-pharmacy-labs-issues-voluntary-nationwide-recall-all-unexpired-sterile-drug-product-lots-due Source: FDA website
Drug Recall 06-19-19
RXQ Compounding
RXQ Compounding announced a voluntary recall of all sterile human and animal products within expiry due to lack of sterility process assurance associated with the production of sterile products. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/rxq-compounding-llc-issues-voluntary-nationwide-recall-all-sterile-products-within-expiry-and Source: FDA website
Drug Recall 06-19-19
Infusion Options
Infusion Options announced a voluntary recall of all lots of sterile products within expiry due to a lack of assurance of sterility. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/infusion-options-inc-issues-voluntary-nationwide-recall-all-lots-all-sterile-products-due-lack Source: FDA website
Drug Recall 06-20-19
Fecal microbiota for transplantation
The Food and Drug Administration (FDA) announced that bacterial infections caused by multi-drug resistant organisms (MDROs) have occurred due to transmission of a MDRO from use of investigational fecal microbiota for transplantation (FMT). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/fecal-microbiota-transplantation-safety-communication-risk-serious-adverse-reactions-due Source: FDA website
Drug Warning 06-14-19
Medtronic MiniMed insulin pumps
The Food and Drug Administration (FDA) is warning about potential cybersecurity risks with certain Medtronic MiniMedTM insulin pumps. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/medical-devices/safety-communications/certain-medtronic-minimed-insulin-pumps-have-potential-cybersecurity-risks-fda-safety-communication Source: FDA website
Drug Warning 06-27-19
Zerbaxa
The Food and Drug Administration (FDA) approved Zerbaxa® (ceftolozane/tazobactam injection) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in individuals 18 years and older. Source: FDA website
New Indication 06-03-19
Emgality
The Food and Drug Administration (FDA) approved Emgality® (galcanezumab-gnlm injection) for the treatment of episodic cluster headache in adults. Source: FDA website
New Indication 06-04-19
Emflaza
The Food and Drug Administration (FDA) approved Emflaza® (deflazacort tablets and oral suspension) to include individuals with Duchenne muscular dystrophy (DMD) who are between 2 and 5 years old. Source: FDA website
New Indication 06-07-19
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for first-line treatment of individuals with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma as monotherapy for individuals whose tumors express programmed death-ligand 1 (PD-L1) (combined positive score ≥1) or in combination with platinum and fluorouracil (FU) regardless of PD-L1 expression. Source: FDA website
New Indication 06-11-19
Nucala
The Food and Drug Administration (FDA) approved Nucala® (mepolizumab injection) for two new methods of administration, an autoinjector and a pre-filled safety syringe, for patients and caregivers to administer once every four weeks after a healthcare professional decides it is appropriate. Nucala is approved for severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis. Source: FDA website
New Dosage Forms and Administration 06-06-19
Polivy
The Food and Drug Administration (FDA) approved PolivyTM (polatuzumab vedotin-piiq) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, in combination with bendamustine and a rituximab product, after at least two prior therapies. Source: FDA website
New Drug 06-10-19
Teva Pharmaceuticals
Teva Pharmaceuticals announced an expanded voluntary recall of six lots of bulk losartan potassium 50 mg and 100 mg tablets due to the detection of an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-pharmaceuticals-usa-inc-expands-voluntary-nationwide-recall-losartan-potassium-50-mg-and-100-mg Source: FDA website
Drug Recall 06-11-19
Glutathione L-reduced powder
The Food and Drug Administration (FDA) warned compounders not to use glutathione L-reduced powder distributed by Letco Medical to compound steroid injectable drugs. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/human-drug-compounding/fda-highlights-concerns-using-dietary-ingredient-glutathione-compound-sterile-injectables Source: FDA website
Drug Warning 06-10-19
Jakafi
The Food and Drug Administration (FDA) approved Jakafi® (ruxolitinib tablets) for the treatment of steroid-refractory acute graft-versus-host disease (GVHD) in individuals aged 12 years and older. Source: FDA website
New Indication 05-24-19
Vraylar
The Food and Drug Administration (FDA) approved Vraylar® (cariprazine capsules) to treat depressive episodes of bipolar I disorder. Source: FDA website
New Indication 05-24-19
Revlimid
The Food and Drug Administration (FDA) approved Revlimid® (lenalidomide capsules) in combination with rituximab for the treatment of adults with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL). Source: FDA website
New Indication 05-28-19
Lyrica
The Food and Drug Administration (FDA) approved Lyrica® (pregabalin capsules and oral solution) as adjunctive therapy in the treatment of partial-onset seizures, to include pediatric individuals 1 month to less than 4 years of age. Source: FDA website
New Indication 05-23-19
Nayzilam
The Food and Drug Administration (FDA) approved Nayzilam® (midazolam nasal spray) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from usual seizure pattern in individuals with epilepsy 12 years of age and older. Source: FDA website
New Formulation 05-17-19
Slynd
The Food and Drug Administration (FDA) approved Slynd (drospirenone tablets) for the prevention of pregnancy. Source: FDA website
New Formulation 05-23-19
Zolgensma
The Food and Drug Administration (FDA) approved Zolgensma® (onasemnogene abeparvovec-xioi injection) for the treatment of pediatric individuals <2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Source: FDA website
New Biologic 05-24-19
Piqray
The Food and Drug Administration (FDA) approved Piqray® (alpelisib tablets) for use with fulvestrant to treat men and postmenopausal women with hormone receptor-positive human epidermal growth factor receptor 2-negative (HR+/HER2−) PIK3CA-mutated advanced or metastatic breast cancer with progression following an endocrine-based regimen. Source: FDA website
New Drug 05-24-19
Pharm D Solutions
Pharma D Solutions announced a voluntary recall of all sterile compounded drug products within expiry due to a potential lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pharm-d-solutions-llc-issues-voluntary-nationwide-recall-all-sterile-compounded-drugs-due-potential-0 Source: FDA website
Drug Recall 05-24-19
Heritage Pharmaceuticals
Heritage Pharmaceuticals announced a voluntary recall of amikacin sulfate injection and prochlorperazine edisylate injection due to sterility test failure. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/heritage-pharmaceuticals-inc-issues-voluntary-nationwide-recall-amikacin-sulfate-injection-usp-1gm4 Source: FDA website
Drug Recall 05-28-19
Novis PR
Novis PR announced a voluntary recall of 5 lots of PECGEN® DMX liquid cough syrup due to incorrect dosage information on the label caused by a typographical error. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novis-pr-llc-issues-voluntary-nationwide-recall-pecgen-dmx-due-labeling-error Source: FDA website
Drug Recall 05-31-19
Bavencio
The Food and Drug Administration (FDA) approved Bavencio® (avelumab injection) in combination with Inlyta® (axitinib tablets) for individuals with advanced renal cell carcinoma. Source: FDA website
New Indication 05-14-19
Cyramza
The Food and Drug Administration (FDA) approved Cyramza® (ramucirumab injection) for the second-line treatment of individuals with hepatocellular carcinoma (HCC) who are alpha fetoprotein (AFP-High) (AFP ≥400 ng/mL). Source: FDA website
New Indication 05-13-19
Xeomin
The Food and Drug Administration (FDA) approved Xeomin® (incobotulinumtoxinA injection) as a first-line treatment for blepharospasm in adults. Source: FDA website
New Indication 05-13-19
Eylea
The Food and Drug Administration (FDA) approved Eylea® (aflibercept injection) to treat all stages of diabetic retinopathy (DR). Source: FDA website
New Indication 05-13-19
Venclexta
The Food and Drug Administration (FDA) approved Venclexta® (venetoclax tablets) in combination with Gazyva® (obinutuzumab injection) for the treatment of individuals with previously untreated chronic lymphocytic leukemia (CLL). Source: FDA website
New Indication 05-15-19
Fragmin
The Food and Drug Administration (FDA) approved Fragmin® (dalteparin sodium injection) for the treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in pediatric individuals 1 month of age and older. Source: FDA website
New Indication 05-16-19
Gattex
The Food and Drug Administration (FDA) approved Gattex® (teduglutide injection) for pediatric individuals 1 year of age and older with short bowel syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support). Source: FDA website
New Indication 05-17-19
Promacta
Novartis announced a voluntary recall of 3 lots of Promacta® (eltrombopag) 12.5 mg oral suspension due to the risk of potential peanut flour contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novartis-issues-voluntary-nationwide-recall-promactar-125-mg-oral-suspension-due-potential-peanut Source: FDA website
Drug Recall 05-13-19
Devices for diabetes management not authorized for sale in the United States
The Food and Drug Administration (FDA) is warning against the use of devices for diabetes management not authorized for sale in the United States. Contact your healthcare provider with questions. More details may be viewed at:https://www.fda.gov/news-events/press-announcements/fda-warns-against-use-unauthorized-devices-diabetes-management Source: FDA website
Drug Warning 05-17-19
Kadcyla
The Food and Drug Administration (FDA) approved Kadcyla® (trastuzumab emtansine injection) for adjuvant (after surgery) treatment of people with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (eBC) who have residual invasive disease after neoadjuvant (before surgery) taxane and Herceptin (trastuzumab)-based treatment. Source: FDA website
Expanded Indication 05-06-19
Sorilux
The Food and Drug Administration (FDA) approved Sorilux® (calcipotriene topical foam) for the treatment of plaque psoriasis of the scalp and body in pediatric individuals 12 years of age and older. Source: FDA website
Expanded Indication 05-10-19
Ruzurgi
The Food and Drug Administration (FDA) approved Ruzurgi (amifampridine tablets) for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in individuals 6 to <17 years of age. Source: FDA website
New Formulation 05-06-19
Vyndaqel and Vyndamax
The Food and Drug Administration (FDA) approved Vyndaqel® (tafamidis meglumine capsules) and VyndamaxTM (tafamidis capsules) for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular (CV) mortality and CV-related hospitalization. Source: FDA website
New Drugs 05-03-19
Vivimed Life Sciences
Vivimed Life Sciences announced a voluntary recall of 19 lots of losartan potassium due to the detection of an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vivimed-life-sciences-pvt-ltd-issues-voluntary-nationwide-recall-losartan-potassium-25-mg-50-mg-and Source: FDA website
Drug Recall 05-03-19
Benlysta
The Food and Drug Administration (FDA) approved Benlysta® (belimumab injection) to include use in children aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) who are currently receiving standard therapy. Source: FDA website
Expanded Indication 04-26-19
Praluent
The Food and Drug Administration (FDA) approved Praluent® (alirocumab injection) to reduce the risk of heart attack, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease. Praluent also approved alone or in combination with other lipid-lowering therapies to treat adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia, to reduce low-density lipoprotein (LDL) cholesterol. Source: FDA website
Expanded Indication 04-28-19
Kalydeco
The Food and Drug Administration (FDA) approved Kalydeco® (ivacaftor capsules and oral granules) to include treatment of cystic fibrosis in individuals 6 months of age and older who have 1 mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive based on clinical and/or in vitro assay data. Source: FDA website
Expanded Indication 04-30-19
Mavyret
The Food and Drug Administration (FDA) approved MavyretTM (glecaprevir/pibrentasvir tablets) to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17. Source: FDA website
Expanded Indication 04-30-19
Tibsovo
The Food and Drug Administration (FDA) approved Tibsovo® (ivosidenib tablets) to include treatment of adults with newly diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase 1 (IDH1) mutation as detected by a Food and Drug Administration (FDA)-approved test who are 75 years old or older or who have comorbidities that preclude use of intensive induction chemotherapy. Source: FDA website
Expanded Indication 05-02-19
Qternmet XR
The Food and Drug Administration (FDA) approved Qternmet® XR (dapagliflozin/saxagliptin/metformin extended-release tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Source: FDA website
New Formulation 05-03-19
Dengvaxia
The Food and Drug Administration (FDA) approved Dengvaxia® (dengue tetravalent vaccine, live, subcutaneous injection) for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas. Source: FDA website
New Vaccine 05-02-19
Bevacizumab
AmEx Pharmacy announced a voluntary recall of one lot of bevacizumab injection due to reported defective delivery system. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amex-pharmacy-issues-voluntary-nationwide-recall-one-lot-bevacizumab-125mg005ml-31-g-syringe-due Source: FDA website
Drug Recall 04-29-19
Teva Pharmaceuticals
Teva Pharmaceuticals announced a voluntary recall of six lots of losartan potassium tablets sold exclusively to Golden State Medical Supply due to the detection of an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-pharmaceuticals-usa-inc-issues-voluntary-nationwide-recall-losartan-potassium-25-mg-and-100-mg Source: FDA website
Drug Recall 04-30-19
Ketorolac tromethamine
Sagent Pharmaceuticals announced a voluntary recall of one lot of ketorolac tromethamine injection due to possible microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sagent-pharmaceuticals-issues-voluntary-nationwide-recall-ketorolac-tromethamine-injection-usp Source: FDA website
Drug Recall 04-30-19
Mycophenolate mofetil
Endo International announced a voluntary recall of one lot of mycophenolate mofetil injection due to observation of a glass fragment after reconstitution. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/par-pharmaceutical-inc-issues-voluntary-nationwide-recall-one-lot-mycophenolate-mofetil-injection Source: FDA website
Drug Recall 05-01-19
Insomnia medications
The Food and Drug Administration (FDA) is warning that rare but serious injuries have happened with certain common prescription insomnia medications because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. Additional labeling will be required. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/news-events/press-announcements/fda-requires-stronger-warnings-about-rare-serious-incidents-related-certain-prescription-insomnia Source: FDA website
Drug Warning 04-30-19
Corlanor
The Food and Drug Administration (FDA) approved Corlanor® (ivabradine oral solution) for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy in pediatric individuals aged 6 months and older who are in sinus rhythm with an elevated heart rate. Source: FDA website
Expanded Indication 04-22-19
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) in combination with Inlyta®(axitinib tablets) for the first-line treatment of individuals with advanced renal cell carcinoma (RCC). Source: FDA website
New Indication 04-22-19
Tranexamic acid in sodium chloride
The Food and Drug Administration (FDA) approved Tranexamic acid in sodium chloride injection in individuals with hemophilia for short-term use to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Source: FDA website
New Formulation 04-15-19
Duobrii
The Food and Drug Administration (FDA) approved DuobriiTM (halobetasol propionate/tazarotene lotion) for the treatment of plaque psoriasis in adults. Source: FDA website
New Formulation 04-25-19
Balversa
The Food and Drug Administration (FDA) approved BalversaTM (erdafitinib tablets) for the treatment of locally advanced or metastatic urothelial carcinoma, with a susceptible fibroblast growth factor receptor (FGFR) 3 or 2 genetic alteration, that has progressed during or after platinum-based chemotherapy. Source: FDA website
New Drug 04-12-19
Skyrizi
The Food and Drug Administration (FDA) approved SkyriziTM (risankizumab-rzaa injection) for the treatment of plaque psoriasis in adults. Source: FDA website
New Drug 04-23-19
Legacy Pharmaceutical Packaging
Legacy Pharmaceutical Packaging announced an expanded voluntary recall of 1 additional lot of losartan potassium tablets due to the detection of trace amounts of an unexpected impurity found in the active pharmaceutical ingredient manufactured by Hetero Labs Limited. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm636624.htm Source: FDA website
Drug Recall 04-25-19
Fentanyl transdermal system
Alvogen announced a voluntary recall of 2 lots of fentanyl transdermal system patches due to product mislabeling. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alvogen-inc-issues-voluntary-nationwide-recall-fentanyl-transdermal-system-due-product-mislabeling Source: FDA website
Drug Recall 04-19-19
Torrent Pharmaceuticals
Torrent Pharmaceuticals announced an expanded recall for 36 lots losartan potassium tablets and 68 lots of losartan potassium/hydrochlorothiazide tablets due to the detection of trace amounts of an unexpected impurity found in the active pharmaceutical ingredient manufactured by Hetero Labs Limited. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm636296.htm Source: FDA website
Drug Recall 04-19-19
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for first-line treatment of individuals with stage III non-small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express programmed death-ligand 1 (PD-L1) (tumor proportion score ≥1%), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Source: FDA website
Expanded Indication 04-11-19
Zykadia
"The Food and Drug Administration (FDA) approved Zykadia® (ceritinib tablets) for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by a Food and Drug Administration (FDA)-approved test. Source: FDA website
New Dosage Form 03-18-19
Welchol
The Food and Drug Administration (FDA) approved Welchol® (colesevelam hydrochloride chewable bar) as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia, to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), and to improve glycemic control in adults with type 2 diabetes mellitus. Source: FDA website
New Dosage Form 04-03-19
Dovato
The Food and Drug Administration (FDA) approved Dovato (dolutegravir/lamivudine tablets) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known resistance to the individual components. Source: FDA website
New Formulation 04-08-19
Evenity
The Food and Drug Administration (FDA) approved EvenityTM (romosozumab-aqqg injection) for the treatment of osteoporosis in postmenopausal women at high risk for fracture or individuals who have failed or are intolerant to other available osteoporosis therapies. Source: FDA website
New Drug 04-09-19
Test strips for at home use
The Food and Drug Administration (FDA) is warning that using pre-owned test strips or test strips not authorized for sale in the United States may lead to inaccurate test results, potentially cause infection, and should not be used. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm635262.htm Source: FDA website
Drug Warning 04-08-19
Opioid pain medications
The Food and Drug Administration (FDA) identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Drugs/DrugSafety/ucm635038.htm Source: FDA website
Drug Warning 04-09-19
Cimzia
The Food and Drug Administration (FDA) approved Cimzia® (certolizumab pegol injection) for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. Source: FDA website
New Indication 03-28-19
Ibrance
The Food and Drug Administration (FDA) approved Ibrance® (palbociclib capsules) in combination with specific endocrine therapies for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in males. Source: FDA website
New Indication 04-04-19
Jatenzo
The Food and Drug Administration (FDA) approved Jatenzo® (testosterone undecanoate capsules) for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Source: FDA website
New Formulation 03-27-19
Avaclyr
The Food and Drug Administration (FDA) approved AvaclyrTM (acyclovir ophthalmic ointment) for the treatment of acute herpetic keratitis (dendritic ulcers) in individuals with herpes simplex (HSV-1 and HSV-2) virus. Source: FDA website
New Formulation 03-29-19
Asceniv
The Food and Drug Administration (FDA) approved AscenivTM (immune globulin intravenous injection) for the treatment of primary humoral immunodeficiency disease in adults and adolescents. Source: FDA website
New Formulation 04-02-19
Duaklir Pressair
The Food and Drug Administration (FDA) approved Duaklir® Pressair® (aclidinium bromide/formoterol fumarate oral inhalation) for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Source: FDA website
New Formulation 03-29-19
Zelnorm
The Food and Drug Administration (FDA) approved ZelnormTM (tegaserod tablets) for the treatment of irritable bowel syndrome with constipation (IBS-C) in women under 65 years of age. Zelnorm was originally approved for the treatment of IBS-C in women and was voluntarily withdrawn due to a potential safety signal. Reintroduction to the market for appropriate individuals comes after a complete safety review by the FDA. Source: FDA website
Reintroduction to Market 03-29-19
Mayzent
The Food and Drug Administration (FDA) approved Mayzent® (siponimod tablets) for the treatment of adults with relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis (SPMS). Source: FDA website
New Drug 03-26-19
Mavenclad
"The Food and Drug Administration (FDA) approved Mavenclad® (cladribine tablets) for the second-line treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Source: FDA website "
New Drug 03-29-19
Venclexta
The Food and Drug Administration (FDA) reviewed data from the BELLINI trial evaluating the use of Venclexta® (venetoclax tablets) in combination with bortezomib and dexamethasone in individuals with multiple myeloma. The interim trial results demonstrated an increased risk of death for individuals receiving Venclexta as compared to the control group. The FDA has required no new patients be enrolled. Those who are receiving clinical benefit can continue treatment in the trial after they reconsent. This statement does not apply to patients taking Venclexta for an approved indication. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Drugs/DrugSafety/ucm634120.htm Source: FDA website
Drug Warning 03-22-19
Avycaz
The Food and Drug Administration (FDA) approved Avycaz® (avibactam/ceftazidime injection) for pediatric individuals aged 3 months and greater for the treatment of complicated intra-abdominal infections (cIAI), used in combination with metronidazole, and for complicated urinary tract infections (cUTI), including pyelonephritis. Source: FDA website
Expanded Indication 03-18-19
Tecentriq
The Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab injection) in combination with carboplatin and etoposide for the initial treatment of extensive-stage small cell lung cancer (ES-SCLC). Source: FDA website
New Indication 03-19-19
Sunosi
The Food and Drug Administration (FDA) approved SunosiTM (solriamfetol tablets) to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). Source: FDA website
New Drug 03-20-19
Zulresso
The Food and Drug Administration (FDA) approved ZulressoTM (brexanolone injection) for the treatment of postpartum depression in adults. Source: FDA website
New Drug 03-19-19
Sodium bicarbonate
Hospira announced a voluntary recall of sodium bicarbonate 8.4% injection due to the presence of particulate matter. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm633663.htm Source: FDA website
Drug Recall 03-18-19
Legacy Pharmaceutical Packaging
Legacy Pharmaceutical Packaging announced a voluntary recall of 43 repackaged lots of losartan tablets due to trace amounts of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm633664.htm and https://www.fda.gov/Safety/Recalls/ucm633671.htm Source: FDA website
Drug Recall 03-18-19
Levoleucovorin
Mylan announced a voluntary recall of two lots of levoleucovorin injection due to the presence of particulate matter. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm633784.htm Source: FDA website
Drug Recall 03-18-19
Tecentriq
The Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab injection) in combination with Abraxane® (paclitaxel protein-bound injection) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumors express programmed death-ligand 1 (PD-L1), as determined by a FDA-approved test. Source: FDA website
New Indication 03-08-19
Dupixent
The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) for the treatment of individuals 12 to 17 years of age with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Source: FDA website
Expanded Indication 03-11-19
Rocklatan
The Food and Drug Administration (FDA) approved RocklatanTM (netarsudil/latanoprost ophthalmic solution) for the reduction of intraocular pressure in individuals with open-angle glaucoma or ocular hypertension. Source: FDA website
New Formulation 03-12-19
Spravato
The Food and Drug Administration (FDA) approved SpravatoTM (esketamine nasal spray) for the treatment of treatment-resistant depression (TRD) in adults in conjunction with an oral antidepressant. Source: FDA website
New Drug 03-05-19
American Health Packaging
American Health Packaging announced a voluntary recall of valsartan tablets due to trace amounts of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm632924.htm Source: FDA website
Drug Recall 03-10-19
Stokes Healthcare
Stokes Healthcare announced a voluntary recall of one lot of pilocarpine 0.1% ophthalmic solution due to a high level of preservative. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm633445.htm Source: FDA website
Drug Recall 03-13-19
Osphena
The Food and Drug Administration (FDA) approved Osphena® (ospemifene tablets) for moderate to severe vaginal dryness due to menopause. Source: FDA website
New Indication 01-29-19
Alimta
The Food and Drug Administration (FDA) approved Alimta® (pemetrexed injection) in combination with pembrolizumab and platinum chemotherapy for the first-line treatment of individuals with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. Source: FDA website
New Indication 01-31-19
Tosymra
The Food and Drug Administration (FDA) approved Tosymra (sumatriptan nasal spray) for the acute treatment of migraine with or without aura in adults. Source: FDA website
New Formulation 01-25-19
Tris Pharma
Tris Pharma updated a previous recall of Infants' Ibuprofen Concentrated Oral Suspension to include 3 additional lots of Ibuprofen Oral Suspension Drops due to potential higher concentrations of ibuprofen. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm627780.htm Source: FDA website
Drug Recall 01-30-19
Cabometyx
The Food and Drug Administration (FDA) approved Cabometyx® (cabozantinib tablets) for individuals with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Source: FDA website
New Indication 01-14-19
Docefrez
The Food and Drug Administration (FDA) approved Docefrez® (docetaxel injection) for combination use with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive breast cancer, combination use with cisplatin and fluorouracil for untreated advanced gastric adenocarcinoma including the gastroesophageal junction, and combination use with cisplatin and fluorouracil for induction treatment of locally advanced squamous cell carcinoma of the head and neck cancer. Source: FDA website
New Indication 01-08-19
Adacel
The Food and Drug Administration (FDA) approved Adacel® (tetanus toxoid/reduced diphtheria toxoid/acellular pertussis [Tdap] vaccine adsorbed injection) for expanded use to allow for repeat vaccination in individuals 10 to 64 years old 8 or more years after the first vaccination. Source: FDA website
New Indication 01-15-19
Vecuronium bromide
Sun Pharmaceutical Industries announced a voluntary recall of vecuronium bromide for injection due to the presence of particulate matter identified as glass. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm629328.htm Source: FDA website
Drug Recall 01-08-19
Lupin Pharmaceuticals
Lupin Pharmaceuticals announced a voluntary recall of ceftriaxone for injection 250 mg, 500 mg, 1 g, and 2 g due to the presence of grey particulate matter in reconstituted vials. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm629298.htm Source: FDA website
Drug Recall 01-06-19
Aurobindo
Aurobindo announced a voluntary recall of 80 lots of amlodipine/valsartan tablets, valsartan/hydrochlorothiazide tablets, and valsartan tablets due to an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm629213.htm Source: FDA website
Drug Recall 01-02-19
Torrent Pharmaceuticals
Torrent Pharmaceuticals is expanding its voluntary recall to include 8 additional lots of losartan potassium tablets due to detection of trace amounts of impurity in the active pharmaceutical ingredient. Contact your healthcare provider with questions. More details may be viewed at:https://www.fda.gov/Safety/Recalls/ucm629261.htm Source: FDA website
Drug Recall 01-04-19
Fluzone Quadrivalent
The Food and Drug Administration (FDA) approved Fluzone® Quadrivalent (influenza vaccine 0.5 mL injection) to include influenza vaccination of children age 6 through 35 months. Source: FDA website
New Indication 01-24-19
Torrent Pharmaceuticals
Torrent Pharmaceuticals is expanding its voluntary recall to include 6 lots of losartan potassium/hydrochlorothiazide tablets due to detection of trace amounts of impurity in the active pharmaceutical ingredient. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm629693.htm Source: FDA website
Drug Recall 01-22-19
Prinston Pharmaceutical
Prinston Pharmaceutical announced a voluntary recall of irbesartan and irbesartan/hydrochlorothiazide tablets due to detection of trace amounts of impurity in the active pharmaceutical ingredient. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm629627.htm Source: FDA website
Drug Recall 01-18-19
Evekeo ODT
The Food and Drug Administration (FDA) approved Evekeo ODT™ (amphetamine sulfate orally disintegrating tablets) for the treatment of attention deficit hyperactivity disorder (ADHD) in pediatric individuals 6 to 17 years of age. Source: FDA website
New Formulation 01-30-19
Gloperba
The Food and Drug Administration (FDA) approved Gloperba® (colchicine oral solution) for the prevention of gout flares in adults. Source: FDA website
New Formulation 01-30-19
Jeuveau
The Food and Drug Administration (FDA) approved Jeuveau™ (prabotulinumtoxinA-xvfs injection) for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults. Source: FDA website
New Formulation 02-01-19
Cablivi
The Food and Drug Administration (FDA) approved Cablivi® (caplacizumab-yhdp injection) for the treatment of adults with acquired thrombotic thrombocytopenic purpura (aTTP). Source: FDA website
New Drug 02-06-19
Levetiracetam
Dr. Reddy's Laboratories announced a voluntary recall of levetiracetam in 0.54% sodium chloride injection 1500 mg/100 mL due to mislabeling. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm630542.htm Source: FDA website
Drug Recall 02-04-19
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) as adjuvant therapy in the treatment of individuals with resected, high-risk stage III melanoma. Source: FDA website
New Indication 02-15-19
Kisqali Femara Co-Pack
The Food and Drug Administration (FDA) approved Kisqali® Femara® Co-Pack (ribociclib/letrozole tablets) as initial endocrine-based therapy for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Source: FDA website
New Indication 02-13-19
Vancomycin
The Food and Drug Administration (FDA) approved premixed Vancomycin injection in a ready-to-use bag approved in adults and pediatric individuals (1 month and older) for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections, and lower respiratory tract infections. Source: FDA website
New Formulation 02-15-19
Egaten
The Food and Drug Administration (FDA) approved Egaten™ (triclabendazole tablets) for the treatment of fascioliasis in individuals 6 years of age and older. Source: FDA website
New Drug 02-13-19
Esperoct
The Food and Drug Administration (FDA) approved Esperoct® (turoctocog alfa pegol injection) for adults and children with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes and perioperative management of bleeding, Source: FDA website
New Drug 02-19-19
Uloric
The Food and Drug Administration (FDA) concluded there is an increased risk of death with Uloric (febuxostat) compared with another gout medication, allopurinol. This conclusion is based on the review of results from a safety trial that found an increased risk of heart-related death and death from all causes with Uloric. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM631824 Source: FDA website
Drug Warning 02-21-19
Lonsurf
The Food and Drug Administration (FDA) approved Lonsurf® (trifluridine/tipiracil tablets) for the treatment of adults with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. Source: FDA website
New Indication 02-25-19
Soliqua
The Food and Drug Administration (FDA) approved Soliqua® (insulin glargine/lixisenatide injection) for use as an add-on to diet and exercise in adults with type 2 diabetes who are uncontrolled on oral antidiabetic medications. Source: FDA website
Expanded Indication 02-25-19
Lotemax SM
The Food and Drug Administration (FDA) approved Lotemax®; SM (loteprednol etabonate ophthalmic gel) for the treatment of postoperative inflammation and pain following ocular surgery. Source: FDA website
New Formulation 02-25-19
Herceptin Hylecta
The Food and Drug Administration (FDA) approved Herceptin Hylecta™ (trastuzumab/hyaluronidase subcutaneous injection) for the treatment of human epidermal growth factor receptor 2 (HER2) overexpressing breast cancer. Source: FDA website
New Formulation 02-28-19
Adhansia XR
The Food and Drug Administration (FDA) approved Adhansia XR™ (methylphenidate extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in individuals 6 years and older. Source: FDA website
New Formulation 02-27-19
Xeljanz/Xeljanz XR
The Food and Drug Administration (FDA) alerted the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of Xeljanz® (tofacitinib tablets) or Xeljanz XR® (tofacitinib extended-release tablets) was used in individuals with rheumatoid arthritis (RA). This dose is only approved for ulcerative colitis (UC). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm632016.htm Source: FDA website
Drug Warning 02-25-19
Drospirenone/ethinyl estradiol
Apotex Corp announced a voluntary recall of 4 lots of drospirenone/ethinyl estradiol tablets for contraception due to the possibility of missing/incorrect tablet arrangement. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm632629.htm Source: FDA website
Drug Recall 03-04-19
AurobindoPharma
AurobindoPharma announced an expansion of its voluntary recall to include 38 additional lots of valsartan and amlodipine/valsartan tablets due to unacceptable amounts of an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm632442.htm Source: FDA website
Drug Recall 03-01-19
Macleods Pharmaceuticals
Macleods Pharmaceuticals Limited announced a voluntary recall of one lot of losartan potassium/hydrochlorothiazide tablets due to trace amounts of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm631880.htm Source: FDA website
Drug Recall 02-25-19
Camber Pharmaceuticals
Camber Pharmaceuticals announced a voluntary recall of 87 lots of valsartan tablets due to trace amounts of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm632395.htm Source: FDA website
Drug Recall 02-28-19
Torrent Pharmaceuticals
Torrent Pharmaceuticals announced a voluntary recall of 60 lots of losartan tablets and 54 lots of losartan/hydrochlorothiazide tablets due to trace amounts of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm632509.htm Source: FDA website
Drug Recall 03-03-19
Myobloc
The Food and Drug Administration (FDA) approved Myobloc® (rimabotulinumtoxinB injection) for the treatment of adults with chronic sialorrhea. Source: FDA website
New Indication 09-03-19
Ofev
The Food and Drug Administration (FDA) approved Ofev® (nintedanib capsules) to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma. Source: FDA website
New Indication 09-06-19
Tybost
The Food and Drug Administration (FDA) approved Tybost® (cobicistat tablets) for use with atazanavir and other antiretroviral agents in the treatment of human immunodeficiency virus-1 (HIV-1) infection in pediatric individuals weighing 35 kg or more. Source: FDA website
Expanded Indication 08-22-19
Sovaldi
The Food and Drug Administration (FDA) approved Sovaldi® (sofosbuvir tablets) for pediatric individuals 3 years of age and older with genotype 2 or 3 chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis in combination with ribavirin. Source: FDA website
Expanded Indication 08-28-19
Harvoni
The Food and Drug Administration (FDA) approved Harvoni® (sofosbuvir/ledipasvir tablets) for pediatric individuals 3 years of age and older with genotype 2 or 3 chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis in combination with ribavirin. Source: FDA website
Expanded Indication 08-28-19
Riomet ER
The Food and Drug Administration (FDA) approved Riomet ER™ (metformin extended-release oral suspension) as an adjunct to diet and exercise to improve glycemic control in adults and pediatric individuals 10 years of age and older with type 2 diabetes mellitus. Source: FDA website
New Formulation 08-29-19
Pacifico National
Pacifico National, doing business as AmEx Pharmacy, announced a voluntary recall of all lots of Bevacizumab injection due to quality and safety concerns. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pacifico-national-inc-dba-amex-pharmacy-issues-voluntary-nationwide-recall-all-lots-bevacizumab Source: FDA website
Drug Recall 08-30-19
Hospira
Hospira announced a voluntary recall of one lot of Bacteriostatic water for injection due to lack of confirmation of sterilization for some vials. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hospira-inc-issues-voluntary-nationwide-recall-one-lot-bacteriostatic-water-injection-usp-due Source: FDA website
Drug Recall 09-06-19
Aczone
The Food and Drug Administration (FDA) approved Aczone® (dapsone topical gel) for treatment of acne vulgaris in individuals aged 9 years and older. Source: FDA website
Expanded Indication 09-12-19
Nucala
The Food and Drug Administration (FDA) approved Nucala® (mepolizumab injection) for use in children as young as 6 years of age who have severe eosinophilic asthma. Source: FDA website
Expanded Indication 09-12-19
Gvoke
The Food and Drug Administration (FDA) approved Gvoke (glucagon injection) for the treatment of severe hypoglycemia in children and adults aged two years and older with diabetes. Source: FDA website
New Formulation 09-10-19
Ibsrela
The Food and Drug Administration (FDA) approved Ibsrela® (tenapanor tablets) for the treatment of irritable bowel syndrome with constipation in adults. Source: FDA website
New Drug 09-12-19
KRS Global Biotechnology
KRS Global Biotechnology announced a voluntary recall of all lots of unexpired drugs intended to be sterile due to lack of assurance of sterility. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/krs-global-biotechnology-inc-issues-voluntary-nationwide-recall-all-human-and-animal-sterile-drug Source: FDA website
Drug Recall 09-13-19
Natpara
Takeda announced a recall for all doses of Natpara injection due to a potential issue related to rubber particulates originating from the Natpara cartridge. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/takeda-issues-us-recall-natparar-parathyroid-hormone-injection-due-potential-rubber-particulate Source: FDA website
Drug Recall 09-05-19
Ibrance, Kisqali, Verzenio
The Food and Drug Administration (FDA) issued a warning that Ibrance® (palbociclib), Kisqali® (ribociclib), and Verzenio® (abemaciclib), used to treat advanced breast cancers, may cause rare but severe inflammation of the lungs. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/ibrance-palbociclib-kisqali-ribociclib-and-verzenio-abemaciclib-drug-safety-communication-due-rare Source: FDA website
Drug Warning 09-13-19
Zantac
The Food and Drug Administration (FDA) has reported that some prescription and over-the-counter (OTC) Zantac® (ranitidine oral) medications used for heartburn may contain a nitrosamine impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/zantac-ranitidine-safety-information-ndma-found-samples-some-ranitidine-medicines Source: FDA website
Drug Warning 09-13-19
Teflaro
The Food and Drug Administration (FDA) approved Teflaro® (ceftaroline fosamil injection) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric individuals less than 2 months of age. Source: FDA website
Expanded Indication 09-17-19
Erleada
The Food and Drug Administration (FDA) approved Erleada® (apalutamide tablets) for the treatment of individuals with metastatic castration-sensitive prostate cancer (mCSPC). Source: FDA website
Expanded Indication 09-18-19
Delstrigo
The Food and Drug Administration (FDA) approved Delstrigo™ (doravirine/lamivudine/tenofovir disoproxil fumarate tablets), as a complete regimen, to include adults with human immunodeficiency virus (HIV)-1 infection who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to Pifeltro (doravirine) or the individual components of Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate). Source: FDA website
Expanded Indication 09-20-19
Pifeltro
The Food and Drug Administration (FDA) approved Pifeltro™ (doravirine tablets), in combination with other antiretroviral agents, to include adults with human immunodeficiency virus (HIV)-1 infection who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to Pifeltro (doravirine) or the individual components of Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate). Source: FDA website
Expanded Indication 09-20-19
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) in combination with Lenvima® (lenvatinib capsules) for the treatment of individuals with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. Source: FDA website
New Indication 09-17-19
Ozobax
The Food and Drug Administration (FDA) approved Ozobax™ (baclofen oral solution) for the treatment of spasticity resulting from multiple sclerosis. It may also have value in individuals with spinal cord injuries or diseases. Source: FDA website
New Formulation 09-18-19
Rybelsus
The Food and Drug Administration (FDA) approved Rybelsus® (semaglutide tablets) to control blood sugar in adults with type 2 diabetes along with diet and exercise. Source: FDA website
New Formulation 09-20-19
Torrent Pharmaceuticals
Torrent Pharmaceuticals announced an expansion of its voluntary recall to include 5 additional lots of losartan potassium tablets due to unacceptable amounts of an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-expands-voluntary-nationwide-recall-losartan-potassium-0 Source: FDA website
Drug Recall 09-20-19
Entresto
The Food and Drug Administration (FDA) approved Entresto® (sacubitril/valsartan tablets) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric individuals aged 1 year and older. Source: FDA website
Expanded Indication 10-02-19
Tybost
The Food and Drug Administration (FDA) approved Tybost® (cobicistat tablets) for coadministration with darunavir in pediatric individuals with human immunodeficiency virus-1 (HIV-1) infection weighing at least 40 kg. Source: FDA website
Expanded Indication 10-04-19
Descovy
The Food and Drug Administration (FDA) approved Descovy® (emtricitabine/tenofovir alafenamide tablets) in at-risk adults and adolescents weighing at least 35 kg for human immunodeficiency virus-1 (HIV-1) pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex. Source: FDA website
New Indication 10-03-19
Wilate
The Food and Drug Administration (FDA) approved Wilate® (von Willebrand Factor/coagulation Factor VIII complex, human injection) for treatment of adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on demand treatment and control of bleeding episodes. Source: FDA website
New Indication 10-08-19
Fasenra Pen
The Food and Drug Administration (FDA) approved Fasenra® Pen (benralizumab pre-fillled, single-use, auto-injector) for self-administration as add-on maintenance treatment for severe eosinophilic asthma. Source: FDA website
New Formulation 10-04-19
Hemady
The Food and Drug Administration (FDA) approved Hemady™ (dexamethasone tablets) for use in combination with other anti-myeloma products for the treatment of adults with multiple myeloma. Source: FDA website
New Formulation 10-03-19
Bortezomib
The Food and Drug Administration (FDA) approved Bortezomib injection for the treatment of adults with multiple myeloma and for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. Source: FDA website
New Formulation 10-04-19
Quzyttir
The Food and Drug Administration (FDA) approved Quzyttir™ (cetirizine injection) for the treatment of acute urticaria in adults and children 6 months of age and older. Source: FDA website
New Formulation 10-04-19
Bonsity
The Food and Drug Administration (FDA) approved Bonsity (teriparatide subcutaneous injection) as a follow-on product for Forteo® (teriparatide subcutaneous injection) for the treatment of osteoporosis in individuals at high risk for fractures. Source: FDA website
New Formulation 10-04-19
Scenesse
The Food and Drug Administration (FDA) approved Scenesse® (afamelanotide subcutaneous implant) to increase pain-free light exposure in adults with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria. Source: FDA website
New Drug 10-08-19
Aklief
The Food and Drug Administration (FDA) approved Aklief® (trifarotene cream) for the treatment of acne vulgaris in individuals 9 and older. Source: FDA website
New Drug 10-04-19
Beovu
The Food and Drug Administration (FDA) approved Beovu® (brolocizumab injection) for the treatment of individuals with wet age-related macular degeneration (AMD). Source: FDA website
New Drug 10-08-19
Innoveix Pharmaceuticals
Innoveix Pharmaceuticals announced a voluntary recall of all sterile compounded drug products, within expiry, to the consumer level due to a lack of assurance of sterility. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/innoveix-pharmaceuticals-inc-issues-voluntary-recall-all-sterile-compounded-drug-products-due-lack Source: FDA website
Drug Recall 10-11-19
Lung injury update
The Food and Drug Administration (FDA) warns the public to stop using tetrahydrocannabinol (THC)-containing vaping products and any vaping products obtained off the street due to reports of lung injuries. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/lung-injury-update-fda-warns-public-stop-using-tetrahydrocannabinol-thc-containing-vaping-products Source: FDA website
Drug Warning 10-04-19
Xarelto
The Food and Drug Administration (FDA) approved Xarelto® (rivaroxaban tablets) to help prevent blood clots for acutely ill individuals without a high risk of bleeding during and after hospitalization. Source: FDA website
Expanded Indication 10-14-19
Xofluza
The Food and Drug Administration (FDA) approved Xofluza™ (baloxavir marboxil tablets) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications. Source: FDA website
Expanded Indication 10-16-19
Nplate
The Food and Drug Administration (FDA) approved Nplate® (romiplostim injection) to expand treatment to newly diagnosed adults with immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Source: FDA website
Expanded Indication 10-17-19
Secuado
The Food and Drug Administration (FDA) approved Secuado® (asenapine transdermal system) for the treatment of adults with schizophrenia. Source: FDA website
New Formulation 10-11-19
Reyvow
The Food and Drug Administration (FDA) approved Reyvow™ (lasmiditan tablets) for the acute treatment of migraine with or without aura in adults. Source: FDA website
New Drug 10-11-19
Viatrexx Bio
Viatrexx Bio announced a voluntary recall of 10 mL sterile injectable vials of products due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viatrexx-bio-incorporated-issues-voluntary-nationwide-recall-sterile-injectables-due-lack-sterility Source: FDA website
Drug Recall 10-15-19
Humate-P
CSL Behring is alerting consumers to an error during Humate-P® (antihemophilic factor/von Willebrand factor complex injection) packaging, the potency data was shifted downwards and this may lead to confusion. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/vaccines-blood-biologics/recalls-biologics/important-drug-information-humate-p-antihemophilic-factorvon-willebrand-factor-complex-human?utm_campaign=Untitled%20Email&utm_medium=email&utm_source=Eloqua Source: FDA website
Drug Warning 10-16-19
Ultomiris
The Food and Drug Administration (FDA) approved Ultomiris® (ravulizumab injection) for the treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adults and pediatric individuals aged one month and older. Source: FDA website
New Indication 10-20-19
Stelara
The Food and Drug Administration (FDA) approved Stelara® (ustekinumab injection) for the treatment of adults with moderately to severely active ulcerative colitis. Source: FDA website
New Indication 10-21-19
Botox
The Food and Drug Administration (FDA) approved Botox® (onabotulinumtoxina injection) for the treatment of lower limb spasticity in pediatric individuals 2 to 17 years of age, excluding spasticity caused by cerebral palsy. Source: FDA website
New Indication 10-18-19
Baxdela
The Food and Drug Administration (FDA) approved Baxdela® (delafloxacin injection and tablets) for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria. Source: FDA website
New Indication 10-24-19
Farxiga
The Food and Drug Administration (FDA) approved Farxiga® (dapagliflozin tablets) to reduce the risk of hospitalization for heart failure in individuals with type 2 diabetes and established cardiovascular (CV) disease or multiple CV risk factors. Source: FDA website
Expanded Indication 10-21-19
Xigduo XR
The Food and Drug Administration (FDA) approved Xigduo® XR (dapagliflozin/metformin extended-release tablets) to reduce the risk of hospitalization for heart failure in individuals with type 2 diabetes and established cardiovascular (CV) disease or multiple CV risk factors. Source: FDA website
Expanded Indication 10-21-19
Fiasp
The Food and Drug Administration (FDA) approved Fiasp® (insulin aspart injection) to include use in insulin infusion pumps for the improvement of glycemic control in adults with type 1 or type 2 diabetes. Source: FDA website
Expanded Indication 10-22-19
Zejula
The Food and Drug Administration (FDA) approved Zejula® (niraparib capsules) for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients, who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status. Source: FDA website
Expanded Indication 10-23-19
Amzeeq
The Food and Drug Administration (FDA) approved Amzeeq™ (minocycline topical foam) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric individuals 9 years of age and older. Source: FDA website
New Formulation 10-18-19
Trikafta
The Food and Drug Administration (FDA) approved Trikafta™ (elexacaftor/ivacaftor/tezacaftor tablets) for the treatment of cystic fibrosis (CF) in individuals 12 years and older who have at least 1 F508del mutation in the cystic fibrosis transmembrane conductance regulator modulator (CFTR) gene. Source: FDA website
New Drug 10-21-19
Sanofi
Sanofi announced a voluntary recall of all Zantac® (ranitidine oral) over-the-counter (OTC) in the United States due to the potential for detection of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sanofi-provides-update-precautionary-voluntary-recall-zantac-otc-us Source: FDA website
Drug Recall 10-23-19
Dr Reddy's Laboratories
Dr. Reddy’s Laboratories announced a voluntary recall of all its ranitidine medications sold in the United States due to confirmed contamination with N-Nitrosodimethylamine (NDMA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-confirms-its-voluntary-nationwide-recall-all-ranitidine-products-us-market Source: FDA website
Drug Recall 10-23-19
Perrigo Company
Perrigo Company announced a voluntary recall of all package sizes of ranitidine due to the possible presence of a nitrosamine impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/perrigo-company-plc-issues-voluntary-worldwide-recall-ranitidine-due-possible-presence-impurity-n Source: FDA website
Drug Recall 10-23-19
Liletta
The Food and Drug Administration (FDA) approved Liletta® (levonorgestrel-releasing intrauterine system) for the prevention of pregnancy for up to six years. Source: FDA website
Expanded Indication 10-28-19
Keppra
The Food and Drug Administration (FDA) approved Keppra® (levetiracetam tablets and oral solution) as monotherapy in the treatment of partial-onset seizures in individuals 1 month of age and older. Source: FDA website
Expanded Indication 10-23-19
Keppra XR
The Food and Drug Administration (FDA) approved Keppra XR® (levetiracetam extended-release tablets) as monotherapy in the treatment of partial-onset seizures in individuals 12 years of age and older. Source: FDA website
Expanded Indication 10-23-19
Vumerity
The Food and Drug Administration (FDA) approved VumerityTM(diroximel fumarate delayed-release capsules) for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Source: FDA website
New Drug 10-29-19
Novitium Pharma
Novitium Pharma announced a voluntary recall of all lots within expiry of ranitidine capsules due to levels of N-Nitrosodimethylamine (NDMA) above the levels recently established by the Food and Drug Administration (FDA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novitium-pharma-issues-voluntary-national-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg Source: FDA website
Drug Recall 10-28-19
Lannett Company
Lannett Company announced a voluntary recall of all lots within expiry of ranitidine syrup 15 mg/mL due to levels of N-Nitrosodimethylamine (NDMA) above the levels recently established by the Food and Drug Administration (FDA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lannett-issues-voluntary-nationwide-recall-ranitidine-syrup-ranitidine-oral-solution-usp-15mgml-due Source: FDA website
Drug Recall 10-25-19
Alprazolam
Mylan announced a voluntary recall of one lot of alprazolam 0.5 mg tablets due to the presence of a foreign substance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-initiates-voluntary-nationwide-recall-one-lot-alprazolam-tablets-usp-c-iv-05 Source: FDA website
Drug Recall 10-26-19
Talicia
The Food and Drug Administration (FDA) approved Talicia® (omeprazole magnesium/amoxicillin/rifabutin delayed-release capsules) approved for the treatment of Helicobacter pylori (H. pylori) infection in adults. Source: FDA website
New Formulation 11-04-19
Fluzone High-Dose Quadrivalent
The Food and Drug Administration (FDA) approved Fluzone® High-Dose Quadrivalent (influenza vaccine injection) for use in adults 65 years of age and older to prevent influenza disease caused by influenza A and B strains contained in the vaccine. Source: FDA website
New Formulation 11-04-19
Reblozyl
The Food and Drug Administration (FDA) approved Reblozyl® (luspatercept-aamt injection) for the treatment of anemia in adults with beta thalassemia who require regular red blood cell (RBC) transfusions. Source: FDA website
New Drug 11-08-19
Fetroja
The Food and Drug Administration (FDA) approved Fetroja® (cefiderocol injection) for the treatment of adults with complicated urinary tract infection (cUTI), including pyelonephritis caused by susceptible Gram-negative microorganisms, with limited or no alternative treatment options. Source: FDA website
New Drug 11-14-19
Brukinsa
The Food and Drug Administration (FDA) approved Brukinsa™ (zanubrutinib capsules) for the treatment of adults with mantle cell lymphoma (MCL) who have received at least one prior therapy. Source: FDA website
New Drug 11-14-19
American Health Packaging
American Health Packaging announced a voluntary recall of eight lots of ranitidine syrup 150 mg/10 mL due to the detection of trace amounts of an unexpected impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-health-packaging-issues-voluntary-nationwide-recall-ranitidine-syrup-ranitidine-oral Source: FDA website
Drug Recall 11-08-19
Aurobindo
Aurobindo Pharma announced a voluntary recall of one lot of ranitidine tablets 150 mg and thirty-seven lots of ranitidine capsules 150 mg, ranitidine capsules 300 mg, and ranitidine syrup 150 mg/mL due to the detection of N-nitrosodimethylamine (NDMA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-initiates-voluntary-nationwide-consumer-level-recall-38-lots-ranitidine Source: FDA website
Drug Recall 11-08-19
Amneal
Amneal announced a voluntary recall of prescription ranitidine tablets 150 mg and 300 mg due to unacceptable levels of N-nitrosodimethylamine (NDMA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-ranitidine-tablets-usp-150mg-and-300mg Source: FDA website
Drug Recall 11-12-19
Lets Gel Kit
Fagron announced a voluntary recall of all unexpired lots of Lets Gel Kit™ (lidocaine hydrochloride/epinephrine bitartrate/tetracaine hydrochloride/sodium metabisulfite/suturagel methylcellulose base/adapter cap/syringes) convenience packs due to potential microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fagron-inc-issues-voluntary-nationwide-recall-lets-gel-kit-convenience-packs-due-potential-microbial Source: FDA website
Drug Recall 11-04-19
MiniMed Pumps
Medtronic announced a recall of specified remote controllers used with MiniMed™ insulin pumps due to potential cybersecurity risks. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-remote-controllers-minimed-insulin-pumps-potential-cybersecurity-risks Source: FDA website
Drug Recall 11-05-19
Biotin
The Food and Drug Administration (FDA) is reminding health care providers and consumers that biotin can significantly interfere with certain lab tests and cause incorrect results. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/medical-devices/safety-communications/update-fda-warns-biotin-may-interfere-lab-tests-fda-safety-communication Source: FDA website
Drug Warning 11-05-19
Calquence
The Food and Drug Administration (FDA) approved Calquence® (acalabrutinib capsules) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Source: FDA website
New Indication 11-21-19
Toujeo
The Food and Drug Administration (FDA) approved Toujeo® (insulin glargine injection) to include treatment of pediatric individuals aged 6 years or older with diabetes mellitus. Source: FDA website
Expanded Indication 12-02-19
Exservan
The Food and Drug Administration (FDA) approved Exservan™ (riluzole oral film) for the treatment of amyotrophic lateral sclerosis (ALS). Source: FDA website
New Formulation 11-22-19
RediTrex
The Food and Drug Administration (FDA) approved RediTrex™ (methotrexate subcutaneous injection) for the management of individuals with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy. It is also indicated for symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy. Source: FDA website
New Formulation 12-02-19
Adakveo
The Food and Drug Administration (FDA) approved Adakveo® (crizanlizumab injection) to reduce the frequency of vaso-occlusive crises in adults and pediatric individuals aged 16 years and older with sickle cell disease. Source: FDA website
New Drug 11-15-19
Oxbryta
The Food and Drug Administration (FDA) approved Oxbryta™ (voxelotor tablets) for adults and pediatric individuals 12 years of age and older with sickle cell disease. Source: FDA website
New Drug 11-25-19
Givlaari
The Food and Drug Administration (FDA) approved Givlaari™ (givosiran subcutaneous injection) for the treatment of adults with acute hepatic porphyria. Source: FDA website
New Drug 11-20-19
Xcopri
The Food and Drug Administration (FDA) approved Xcopri® (cenobamate tablets) for the treatment of partial-onset seizures in adults. Source: FDA website
New Drug 11-21-19
Golden State Medical Supply
Golden State Medical announced a voluntary recall of all lots within expiry of ranitidine capsules 150 mg and 300 mg due to the potential presence of N-nitrosodimethylamine (NDMA) above levels established by the Food and Drug Administration (FDA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/golden-state-medical-supply-inc-issues-voluntary-nationwide-recall-ranitidine-hydrochloride-150mg Source: FDA website
Drug Recall 11-19-19
Precision Dose
Precision Dose announced a voluntary recall of 5 lots of ranitidine oral solution due to potential N-nitrosodimethylamine (NDMA) amounts above levels established by the Food and Drug Administration (FDA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/precision-dose-inc-issues-voluntary-nationwide-recall-ranitidine-oral-solution-usp-150-mg10-ml-due Source: FDA website
Drug Recall 11-21-19
Tecentriq
The Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab injection) for use in combination with Abraxane®(paclitaxel protein-bound injection) and carboplatin for first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Source: FDA website
New Indication 12-04-19
Xeljanz XR
The Food and Drug Administration (FDA) approved Xeljanz XR® (tofacitinib extended-relesae tablets) for the treatment of adults with moderately to severely active ulcerative colitis (UC) after an inadequate response or intolerance to tumor necrosis factor (TNF) blockers. Source: FDA website
New Indication 12-13-19
Vascepa
The Food and Drug Administration (FDA) approved Vascepa® (icosapent ethyl capsules) as an adjunctive therapy to reduce the risk of cardiovascular (CV) events among adults with elevated triglyceride levels of 150 milligrams per deciliter or higher. Individuals must also have either established CV disease or diabetes and two or more additional risk factors for CV disease. Source: FDA website
New Indication 12-13-19
Vyondys 53
The Food and Drug Administration (FDA) approved Vyondys 53™ (golodirsen injection) for the treatment of Duchenne muscular dystrophy (DMD) in individuals who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. Source: FDA website
New Drug 12-13-19
Unapproved stem cell and exosome products
The Food and Drug Administration (FDA is warning consumers of reports of serious adverse events due to marketing of unapproved stem cell and exosome products. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/about-fda/medical-product-safety-information/public-safety-alert-due-marketing-unapproved-stem-cell-and-exosome-products Source: FDA website
Drug Warning 12-10-19
Basic Reset and Biogenyx
The Food and Drug Administration (FDA) alerted consumers of a recall of 25 drug, dietary supplement, and medical device product lines distributed by Basic Reset and Biogenyx due to not meeting FDA regulations. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/news-events/press-announcements/fda-underscores-consumers-should-not-use-drugs-dietary-supplements-and-devices-recalled-basic-reset Source: FDA website
Drug Recall 12-10-19
Xtandi
The Food and Drug Administration (FDA) approved Xtandi® (enzalutamide capsules) for individuals with metastatic castration-sensitive prostate cancer (mCSPC). Source: FDA website
Expanded Indication 12-16-19
Fiasp
The Food and Drug Administration (FDA) approved Fiasp® (insulin aspart injection) for use as a new mealtime insulin option for children with diabetes. Source: FDA website
Expanded Indication 12-19-19
Mycamine
The Food and Drug Administration (FDA) approved Mycamine™ (micafungin sodium injection) for the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination in pediatric individuals younger than 4 months of age. Source: FDA website
Expanded Indication 12-20-19
Lynparza
The Food and Drug Administration (FDA) approved Lynparza® (olaparib tablets) for the maintenance treatment of adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Individuals will be selected for therapy based on an FDA-approved companion diagnostic. Source: FDA website
New Indication 12-30-19
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of individuals with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Source: FDA website
New Indication 01-08-20
Arazlo
The Food and Drug Administration (FDA) approved Arazlo™ (tazarotene lotion) for the topical treatment of acne vulgaris in individuals 9 years of age and older. Source: FDA website
New Formulation 12-18-19
Conjupri
The Food and Drug Administration (FDA) approved Conjupri® (levamlodipine tablets) for the treatment of hypertension. Source: FDA website
New Formulation 12-20-19
Ervebo
The Food and Drug Administration (FDA) approved Ervebo® (Ebola virus vaccine injection) for the prevention of Ebola virus disease caused by Zaire ebolavirus in individuals 18 years of age and older. Source: FDA website
New Vaccine 12-20-19
Enhertu
The Food and Drug Administration (FDA) approved Enhertu® (fam-trastuzumab deruxtecan-nxki injection) for the third-line treatment of adults with unresectable or metastatic HER2-positive breast cancer. Source: FDA website
New Drug 12-20-19
Caplyta
The Food and Drug Administration (FDA) approved Caplyta® (lumateperone capsules) for the treatment of schizophrenia in adults Source: FDA website
New Drug 12-20-19
Dayvigo
The Food and Drug Administration (FDA) approved Dayvigo™ (lemborexant tablets) for the treatment of adults with insomnia that is characterized by difficulties with sleep onset and/or sleep maintenance. Source: FDA website
New Drug 12-20-19
Ubrelvy
The Food and Drug Administration (FDA) approved Ubrelvy™ (ubrogepant tablets) for the treatment of acute migraines that present with or without aura in adults. Source: FDA website
New Drug 12-23-19
Padcev
The Food and Drug Administration (FDA) approved Padcev™ (enfortumab vedotin-ejfv injection) for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. Source: FDA website
New Drug 12-18-19
Ayvakit
The Food and Drug Administration (FDA) approved Ayvakit™ (avapritinib tablets) for the treatment of adults with unresectable or metastatic PDGFRA exon 18 mutant gastrointestinal stromal tumor (GIST). Source: FDA website
New Drug 01-09-19
Mavidon
Mavidon announced a voluntary recall of all lots of products manufactured at their facility including due to contamination with Burkholderia cepacia. Contact your healthcare provider with questions. More details including affected products may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mavidon-issues-voluntary-worldwide-recall-all-manufactured-products-due-burkholderia-cepacia Source: FDA website
Drug Recall 12-26-19
Glenmark Pharmaceuticals
Glenmark Pharmaceuticals announced a voluntary recall of prescription ranitidine 150 mg and 300 mg tablets because they may contain unacceptable levels of N-nitrosodimethylamine (NDMA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/glenmark-pharmaceuticals-inc-usa-voluntarily-recalls-all-unexpired-lots-its-ranitidine-tablets-and Source: FDA website
Drug Recall 12-18-19
Mirtazapine
Aurobindo announced a voluntary recall of one lot of mirtazapine tablets due to a label error on declared strength. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/aurobindo-pharma-usa-inc-issues-voluntary-nationwide-recall-mirtazapine-tablets-lot-number Source: FDA website
Drug Recall 01-02-20
Levetiracetam
Lannett Company announced a voluntary recall of two lots of levetiracetam oral solution due to contamination with Bacillus subtilis. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lannett-issues-voluntary-nationwide-recall-levetiracetam-oral-solution-100mgml-due-microbial Source: FDA website
Drug Recall 12-20-19
Denton Pharma
Denton Pharma, doing business as Northwind Pharmaceuticals, announced a voluntary recall of all unexpired lots of ranitidine tablets due to potential presence of the impurity N-nitrosodimethylamine (NDMA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/denton-pharma-inc-dba-northwind-pharmaceuticals-voluntarily-recalls-all-unexpired-lots-its Source: FDA website
Drug Recall 01-08-20
Nizatidine
Mylan announced a voluntary recall of 3 lots of nizatidine capsules due to detected trace amounts of an impurity N-nitrosodimethylamine (NDMA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-initiates-voluntary-nationwide-recall-three-lots-nizatidine-capsules-usp-due-detection-trace Source: FDA website
Drug Recall 01-08-20
Appco Pharma
Appco Pharma announced a voluntary recall of all quantities and lots within expiry of ranitidine capsules due to the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above those established as acceptable by the Food and Drug Administration (FDA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/appco-pharma-llc-issues-voluntary-nationwide-recall-ranitidine-hydrochloride-capsules-150-mg-and-300 Source: FDA website
Drug Recall 01-08-20
Gabapentin and pregabalin
The Food and Drug Administration (FDA) is warning that serious breathing difficulties may occur in individuals using gabapentin or pregabalin who have respiratory risk factors. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-serious-breathing-problems-seizure-and-nerve-pain-medicines-gabapentin-neurontin Source: FDA website
Drug Warning 12-19-19
Ozempic
The Food and Drug Administration (FDA) approved Ozempic® (semaglutide injection) for reducing the risk of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack, or non-fatal stroke in adults with type 2 diabetes and established cardiovascular disease (CVD). Source: FDA website
Expanded Indication 01-16-20
Valtoco
The Food and Drug Administration (FDA) approved Valtoco® (diazepam nasal spray) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (ie, seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in individuals with epilepsy 6 years of age and older. Source: FDA website
New Formulation 01-13-20
Monoferric
The Food and Drug Administration (FDA) approved Monoferric™ (ferric derisomaltose injection) for the treatment of iron deficiency anemia in adults who have intolerance to oral iron or have had unsatisfactory response to oral iron or who have non-hemodialysis dependent chronic kidney disease. Source: FDA website
New Formulation 01-16-20
Lamotrigine
Taro Pharmaceuticals announced a voluntary recall of one lot of lamotrigine 100 mg tablets due to cross contamination with a small amount of another drug substance (enalapril maleate) used to manufacture another product at the same facility. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/taro-pharmaceuticals-usa-inc-issues-voluntary-nationwide-recall-lamotrigine-tablets-usp-100-mg-100 Source: FDA website
Drug Recall 01-10-20
AXIA Pharmaceutical
AXIA Pharmaceutical announced a voluntary recall of all unused sterile drug products within expiry due to a lack of assurance of sterility. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fusion-iv-pharmaceuticals-inc-dba-axia-pharmaceutical-issues-voluntary-nationwide-recall-all-sterile Source: FDA website
Drug Recall 01-17-20
Lorcaserin
The Food and Drug Administration (FDA) is warning that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medication Belviq® (lorcaserin tablets) and Belviq XR® (lorcaserin extended release tablets). It cannot yet be concluded that lorcaserin contributes to the cancer risk. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/belviq-belviq-xr-lorcaserin-drug-safety-communication-due-possible-increased-risk-cancer Source: FDA website
Drug Warning 01-14-20
Tepezza
The Food and Drug Administration (FDA) approved TepezzaTM (teprotumumab-trbw injection) for the treatment of thyroid eye disease (TED). Source: FDA website
New Drug 01-21-20
Tazverik
The Food and Drug Administration (FDA) approved TazverikTM (tazemetostat tablets) for the treatment of adults and pediatric individuals aged 16 years and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection. Source: FDA website
New Drug 01-23-20
FUSION IV Pharmaceuticals
FUSION IV Pharmaceuticals announced a voluntary recall of all unused sterile drug products within expiry due to a lack of assurance of sterility. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fusion-iv-pharmaceuticals-inc-dba-axia-pharmaceutical-issues-voluntary-nationwide-recall-all-sterile Source: FDA website
Drug Recall 01-21-20
ABH Nature's Products, ABH Pharma, and Stocknutra.com
ABH Nature's Products, ABH Pharma, and Stocknutra.com announced a voluntary recall of all lots of dietary supplement products manufactured and sold between January 2013 and November 2019 due to significant violations of current good manufacturing practice regulations. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abh-natures-products-inc-abh-pharma-inc-and-stocknutracom-inc-issues-nationwide-recall-all-lots Source: FDA website
Drug Recall 01-23-20
Dificid
The Food and Drug Administration (FDA) approved Dificid® (fidaxomicin tablets) for use in pediatric individuals 6 months of age and older for the treatment of Clostridioides difficile (C. difficile) associated diarrhea (CDAD). The approval includes a new oral suspension formulation. Source: FDA website
Expanded Indication 01-27-20
Sabril
The Food and Drug Administration (FDA) approved Sabril® (vigabatrin tablets) for use in individuals 2 years of age and older with refractory complex partial seizures. Source: FDA website
Expanded Indication 01-24-20
Invokamet, Invokamet XR
The Food and Drug Administration (FDA) approved Invokamet® (canagliflozin/metformin tablets) and Invokamet® XR (canagliflozin/metformin extended release tablets) to reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria. Source: FDA website
Expanded Indication 01-27-20
Trijardy XR
The Food and Drug Administration (FDA) approved Trijardy™ XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets) to lower blood sugar in adults with type 2 diabetes, along with diet and exercise. Source: FDA website
New Formulation 01-27-20
Ajovy Autoinjector
The Food and Drug Administration (FDA) approved Ajovy® (fremanezumab autoinjector) for the preventive treatment of migraine in adults. Source: FDA website
New Formulation 01-28-20
Bynfezia Pen
The Food and Drug Administration (FDA) approved Bynfezia Pen™ (octreotide acetate subcutaneous injection) for reduction of growth hormone (GH) and insulin-like growth factor 1 (IGF-1) [somatomedin C] in adults with acromegaly who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. It is also approved for treatment of severe diarrhea/flushing episodes associated with metastatic carcinoid tumors in adults and for treatment of profuse watery diarrhea associated with vasoactive intestinal peptide tumors (VIPomas) in adults. Source: FDA website
New Formulation 01-28-20
Audenz
The Food and Drug Administration (FDA) approved Audenz™ (influenza A H5N1 monovalent vaccine injection) for active immunization for the prevention of disease in individuals 6 months of age and older at increased risk of exposure to the influenza A H5N1 virus subtype contained in the vaccine. Source: FDA website
New Formulation 02-03-20
Palforzia
The Food and Drug Administration (FDA) approved Palforzia™ (peanut allergen oral powder) for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. Source: FDA website
New Drug 01-31-20
Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAXliquid
Efficient Laboratories announced a voluntary recall of three lots of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAXliquid. These products are used to treat symptoms of the flu and the common cold. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/efficient-laboratories-inc-issues-voluntary-nationwide-recall-rompe-pecho-ex-rompe-pecho-cf-and Source: FDA website
Drug Recall 02-03-20
Clozapine
The Food and Drug Administration (FDA) is strengthening an existing warning that constipation caused by the schizophrenia medication clozapine can progress to serious bowel complications. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/clozaril-fazaclo-odt-versacloz-clozapine-drug-safety-communication-fda-strengthens-warning-untreated Source: FDA website
Drug Warning 01-28-20
Pemfexy
The Food and Drug Administration (FDA) approved Pemfexy™ (pemetrexed injection) ready-to-dilute formulation for locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin; locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as maintenance treatment; locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy as a single agent; and malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery in combination with cisplatin. Source: FDA website
New Formulation 02-14-20
Twirla
The Food and Drug Administration (FDA) approved Twirla® (levonorgestrel/ethinyl estradiol transdermal) as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. Source: FDA website
New Formulation 02-14-20
Pizensy
The Food and Drug Administration (FDA) approved Pizensy (lactitol powder for oral solution) for the treatment of chronic idiopathic constipation in adults. Source: FDA website
New Formulation 02-12-20
Anjeso
The Food and Drug Administration (FDA) approved Anjeso™ (meloxicam injection) for the management of moderate-to-severe pain, alone or in combination with other non-non-steroidal anti-inflammatory drugs (NSAIDs). Source: FDA website
New Formulation 02-20-20
Nexletol
The Food and Drug Administration (FDA) approved Nexletol™ (bempedoic acid tablets) as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Source: FDA website
New Drug 02-21-20
MiniMed 600 Series insulin pumps
Medtronic announced a voluntary recall of certain MiniMed 600 Series insulin pumps due to a missing or broken retainer ring. Contact your healthcare provider with questions. More details including affected pumps may be viewed at: https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-minimed-insulin-pumps-incorrect-insulin-dosing Source: FDA website
Drug Recall 02-12-20
Belviq; Belviq XR
Eisai has decided to withdraw the weight loss drugs Belviq® (lorcaserin tablets) and Belviq XR® (lorcaserin extended-release tablets) from the market. This is based on a recently completed analysis of data from the CAMELLIA-TIMI 61 trial. The Food and Drug Administration (FDA) is advising healthcare professionals to stop prescribing lorcaserin and to contact those who have been treated with the drug. Individuals should be informed of the increased occurrence of cancer seen in the clinical trial. Source: FDA website; Eisai website
Drug Withdrawal 02-14-20
Voltaren Arthritis Pain
The Food and Drug Administration (FDA) approved Voltaren Arthritis Pain (diclofenac topical 1% gel) for over-the-counter (OTC) use for the temporary relief of arthritis pain. Source: FDA website
New OTC 02-17-20
Pataday Twice Daily Relief
The Food and Drug Administration (FDA) approved Pataday® Twice Daily Relief (olopatadine hydrochloride ophthalmic 0.1% solution and drops) for over-the-counter (OTC) use for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair, or dander. Source: FDA website
New OTC 02-17-20
Pataday Once Daily Relief
The Food and Drug Administration (FDA) approved Pataday® Once Daily Relief (olopatadine hydrochloride ophthalmic 0.2% solution and drops) for over-the-counter (OTC) use for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair, or dander. Source: FDA website
New OTC 02-17-20
Trulicity
The Food and Drug Administration (FDA) approved Trulicity® (dulaglutide injection) for the reduction of cardiovascular (CV) risks in individuals with type 2 diabetes. Source: FDA website
Expanded Indication 02-14-20
Nerlynx
The Food and Drug Administration (FDA) approved Nerlynx® (neratinib tablets) in combination with capecitabine for the treatment of adults with advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. Source: FDA website
Expanded Indication 02-26-20
Fluad Quadrivalent
The Food and Drug Administration (FDA) approved Fluad® Quadrivalent (influenza vaccine injection) for active immunization against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine in individuals 65 years of age and older. Source: FDA website
Expanded Indication 02-24-20
ArmonAir Digihaler
The Food and Drug Administration (FDA) approved ArmonAir® Digihaler™ (fluticasone propionate oral inhalation powder) for the maintenance treatment of asthma in individuals 12 years and older. Source: FDA website
New Formulation 02-24-20
Nexlizet
The Food and Drug Administration (FDA) approved Nexlizet™ (bempedoic acid/ezetimibe tablets) as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein cholesterol (LDL)-C. Source: FDA website
New Formulation 02-26-20
Barhemsys
The Food and Drug Administration (FDA) approved Barhemsys® (amisulpride injection) for the treatment of postoperative nausea and vomiting in individuals who have received antiemetic prophylaxis with an agent of a different class or who have not received prophylaxis. It is also approved for the prevention of postoperative nausea and vomiting, either alone or in combination with an antiemetic of a different class. Source: FDA website
New Drug 02-27-20
Nurtec
The Food and Drug Administration (FDA) approved Nurtec® (rimegepant orally disintegrating tablets) for the acute treatment of migraine in adults. Source: FDA website
New Drug 02-27-20
Vyepti
The Food and Drug Administration (FDA) approved Vyepti™ (eptinezumab injection) for the preventive treatment of migraine in adults. Source: FDA website
New Drug 02-21-20
American Health Packaging
American Health Packaging announced a voluntary recall of eleven lots of ranitidine tablets due to the potential for N-Nitrosodimethylamine (NDMA) amounts above levels established by the Food and Drug Administration (FDA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/american-health-packaging-issues-voluntary-nationwide-recall-ranitidine-tablets-usp-150-mg-100-count Source: FDA website
Drug Recall 02-27-20
Phenytoin
Taro Pharmaceuticals announced a voluntary recall of two lots of phenytoin oral suspension due to possible underdosing or overdosing. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/taro-pharmaceuticals-usa-issues-voluntary-nationwide-recall-phenytoin-oral-suspension-usp-125-mg5ml Source: FDA website
Drug Recall 02-21-20
Symtuza
The Food and Drug Administration (FDA) approved Symtuza® (darunavir/cobicistat/emtricitabine/tenofovir alafenamide tablets) for the treatment of human immunodeficiency virus (HIV)-1 infection in pediatric individuals weighing at least 40kg who are treatment-naive or virologically suppressed (<50 copies/mL) on a stable antiretroviral regimen for at least 6 months and have no known substitutions associated with resistance to darunavir or tenofovir. Source: FDA website
Expanded Indication 03-05-20
Durysta
The Food and Drug Administration (FDA) approved Durysta™ (bimatoprost ophthalmic implant) for the reduction of intraocular pressure (IOP) in individuals with open angle glaucoma (OAG) or ocular hypertension (OHT). Source: FDA website
New Formulation 03-05-20
Sarclisa
The Food and Drug Administration (FDA) approved Sarclisa® (isatuximab injection) for the treatment of adults with multiple myeloma, in combination with pomalidomide and dexamethasone, who have received at least two prior therapies. Source: FDA website
New Drug 03-02-20
Ketorolac tromethamine
Hikma Pharmaceuticals announced an expansion of a previous voluntary recall of certain lots of ketorolac tromethamine injection due to the presence of particulate matters. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hikma-pharmaceuticals-usa-inc-extends-voluntary-nationwide-recall-ketorolac-tromethamine-injection Source: FDA website
Drug Recall 03-05-20
Singulair
The Food and Drug Administration (FDA) announced it is requiring a boxed warning for Singulair® (montelukast tablets and oral granules) and its generics to strengthen an existing warning about the risk of neuropsychiatric events associated with this asthma and allergic rhinitis medication. The new warning will advise against prescribing it for individuals with mild symptoms, particularly those with allergic rhinitis. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/singulair-montelukast-and-all-montelukast-generics-strengthened-boxed-warning-due-restricting-use Source: FDA website
Drug Warning 03-04-20
Isturisa
The Food and Drug Administration (FDA) approved Isturisa® (osilodrostat tablets) for the treatment of Cushing’s disease in adults for whom pituitary surgery is not an option or was unsuccessful. Source: FDA website
New Drug 03-06-20
Ofev
The Food and Drug Administration (FDA) approved Ofev® (nintedanib capsules) to treat individuals with chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype. Source: FDA website
New Indication 03-09-20
Opdivo and Yervoy
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) and Yervoy® (ipilimumab injection) to treat hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. Source: FDA website
New Indication 03-11-20
Epclusa
The Food and Drug Administration (FDA) approved Epclusa® (sofosbuvir/velpatasvir tablets) to treat hepatitis C virus (HCV) in children ages 6 years and older or weighing at least 37 pounds with any of the six HCV genotypes without cirrhosis or with mild cirrhosis. Epclusa in combination with ribavirin is indicated for the treatment of children 6 years and older or weighing at least 37 pounds with severe cirrhosis. Source: FDA website
Expanded Indication 03-19-20
Eucrisa
The Food and Drug Administration (FDA) approved Eucrisa® (crisaborole ointment) for the treatment of mild to moderate atopic dermatitis in pediatric individuals as young as 3 months old. Source: FDA website
Expanded Indication 03-24-20
EpiPen; EpiPen Jr
The Food and Drug Administration (FDA) is alerting consumers and healthcare providers that EpiPen® (epinephrine 0.3 mg) and EpiPen Jr® (epinephrine 0.15 mg) auto-injectors, and authorized generic versions, may have delayed injection or be prevented from properly injecting. Contact your healthcare provider with questions. More details may be viewed at:https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-and-health-care-professionals-epipen-auto-injector-errors-related-device Source: FDA website
Drug Warning 03-24-20
Zeposia
The Food and Drug Administration (FDA) approved Zeposia® (ozanimod capsules) for the treatment of relapsing forms of multiple sclerosis (MS) to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Source: FDA website
New Drug 03-25-20
Phytonadione
Dr. Reddy’s announced a voluntary recall of phytonadione injectable emulsion 10 mg/mL single-dose ampules due to breaking and shattering upon opening. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-laboratories-issues-voluntary-nationwide-recall-phytonadione-injectable-emulsion-usp-10 Source: FDA website
Drug Recall 03-26-20
Taltz
The Food and Drug Administration (FDA) approved Taltz® (ixekizumab injection) for the treatment of pediatric individuals 6 years of age and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Source: FDA website
Expanded Indication 03-27-20
Imfinzi
The Food and Drug Administration (FDA) approved Imfinzi® (durvalumab injection) as a first-line treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care (SoC) chemotherapies, etoposide plus either carboplatin or cisplatin (platinum-etoposide). Source: FDA website
New Indication 03-27-20
Triferic
The Food and Drug Administration (FDA) approved Triferic® (ferric pyrophosphate citrate injection) for the replacement of iron to maintain hemoglobin in adults with hemodialysis-dependent chronic kidney disease (HDD-CKD). Source: FDA website
New Formulation 03-27-20
Sevenfact
The Food and Drug Administration (FDA) approved Sevenfact® [coagulation factor VIIa (recombinant)-jncw injection] for the treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors. Source: FDA website
New Drug 04-01-20
Ranitidine
The Food and Drug Administration (FDA) is requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/all-ranitidine-products-zantac-press-release-fda-requests-removal Source: FDA website
Drug Warning 04-01-20
Reblozyl
The Food and Drug Administration (FDA) approved Reblozyl® (luspatercept-aamt injection) for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adults with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T). Source: FDA website
New Indication 04-03-20
Braftovi
The Food and Drug Administration (FDA) approved Braftovi® (encorafenib capsules) in combination with cetuximab for the treatment of Brafv600E-mutant metastatic colorectal cancer (CRC) after prior therapy. Source: FDA website
New Indication 04-08-20
Koselugo
The Food and Drug Administration (FDA) approved KoselugoTM (selumetinib capsules) for the treatment of children 2 years of age and older with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs). Source: FDA website
New Drug 04-10-20
Ivermectin
There has been increased public visibility of the antiparasitic drug ivermectin after the announcement of a research article that described the effect of ivermectin on SARS-CoV-2 in a laboratory setting. The Food and Drug Administration (FDA) is concerned about the health of consumers who may self-medicate by taking ivermectin products intended for animals. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/ivermectin-intended-animals-letter-stakeholders-do-not-use-humans-treatment-covid-19 Source: FDA website
Drug Warning 04-11-20
Fecal microbiota for transplantation
Due to the potential risk of transmission of SARS-CoV-2 via fecal microbiota for transplantation (FMT), the Food and Drug Administration (FDA) has determined that additional protections are needed for any investigational use of FMT. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/fecal-microbiota-transplantation-new-safety-information-regarding-additional-protections-screening Source: FDA website
Drug Warning 04-11-20
Senna laxatives
Magno-Humphries Laboratories announced a voluntary recall of one lot of Basic Drugs Brand of Senna laxative tablets due to mislabeling. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/magno-humphries-laboratories-inc-issues-voluntary-nationwide-recall-basic-drugs-brand-senna-laxative Source: FDA website
Drug Recall 04-15-20
Limbrel
Primus Pharmaceuticals announced a voluntary recall of all lots within expiry of the prescription medical food Limbrel® (flavocoxid capsules) due to rare but serious and reversible adverse events. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/primus-announces-voluntary-nationwide-recall-all-lots-within-expiry-prescription-medical-food Source: FDA website
Drug Recall 04-15-20
Nizatidine
Amneal Pharmaceuticals announced a voluntary recall of three lots of nizatidine oral solution due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding levels established by the Food and Drug Administration (FDA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-nizatidine-oral-solution-15-mgml-due Source: FDA website
Drug Recall 04-15-20
Gericare Eye Wash
Kareway Products announced a voluntary recall of Gericare Eye Wash due to potential microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kareway-products-inc-issues-voluntary-nationwide-recall-gericare-eye-wash-due-complaints-received Source: FDA website
Drug Recall 04-15-20
Jelmyto
The Food and Drug Administration (FDA) approved JelmytoTM (mitomycin for pyelocalyceal solution) for the treatment of adults with low-grade upper tract urothelial cancer (LG-UTUC). Source: FDA website
New Formulation 04-15-20
Epclusa
The Food and Drug Administration (FDA) approved Epclusa® (sofosbuvir/velpatasvir tablets) to treat hepatitis C virus (HCV) in children ages 6 years and older or weighing at least 37 pounds with any of the six HCV genotypes-or strains-without cirrhosis or with mild cirrhosis. Source: FDA website
Expanded Indication 04-15-20
Tetracycline
Avet Pharmaceuticals announced a voluntary recall of tetracycline 250 mg and 500 mg capsules due to failed dissolution specifications. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avet-pharmaceuticals-inc-issues-voluntary-nationwide-recall-tetracycline-hcl-capsules-usp-250-mg-and Source: FDA website
Drug Recall 04-17-20
Clopidogrel
International Laboratories announced a voluntary recall of one lot of clopidogrel 75 mg tablets due to mislabeling. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/international-laboratories-llc-issues-voluntary-nationwide-recall-one-1-lot-clopidogrel-tablets-usp Source: FDA website
Drug Recall 04-17-20
Tukysa
The Food and Drug Administration (FDA) approved TukysaTM (tucatinib tablets) for second-line or greater treatment of adults with advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer, including individuals with brain metastases, in combination with trastuzumab and capecitabine. Source: FDA website
New Drug 04-17-20
Pemazyre
The Food and Drug Administration (FDA) approved PemazyreTM (pemigatinib tablets) for treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement detected by FDA-approved test. Source: FDA website
New Drug 04-17-20
Cymbalta
The Food and Drug Administration (FDA) approved Cymbalta® (duloxetine capsules) for the treatment of fibromyalgia in individuals 13 to 17 years of age. Source: FDA website
Expanded Indication 04-20-20
Ketorolac tromethamine
Fresenius Kabi USA announced a voluntary recall of 13 lots of ketorolac tromethamine injection due to the presence of particulate matter. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-13-lots-ketorolac-tromethamine-injection-usp-due Source: FDA website
Drug Recall 04-20-20
Ceftazidime and dextrose
Braun Medical Inc. announced a voluntary recall of 1 lot of ceftazidime and dextrose for injection due to out-of-specification stability test results for high molecular weight polymers. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-medical-inc-issues-voluntary-nationwide-recall-one-1-lot-ceftazidime-injection-usp-and Source: FDA website
Drug Recall 04-20-20
Imbruvica
The Food and Drug Administration (FDA) approved Imbruvica® (ibrutinib tablets and capsules) to include combination use with rituximab for the initial treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Source: FDA website
Expanded Indication 04-21-20
True Metrix Air
Trividia Health announced a voluntary recall of 1 isolated True Metrix Air blood glucose meter due to being packaged into a True Metrix blood glucose meter kit and having an incorrect factory-set unit of measure. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/trividia-health-inc-issues-nationwide-voluntary-recall-isolated-true-metrix-air-blood-glucose-meter Source: FDA website
Drug Recall 04-21-20
Trodelvy
The Food and Drug Administration (FDA) approved TrodelvyTM (sacituzumab govitecan-hziy injection) for third-line or greater treatment of adults with metastatic triple-negative breast cancer (TNBC). Source: FDA website
New Drug 04-22-20
Cannabidiol
The Food and Drug Administration (FDA) has sent warning letters to 2 companies for illegally selling unapproved products containing cannabidiol (CBD). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/news-events/press-announcements/fda-warns-companies-illegally-selling-cbd-products-treat-medical-conditions-opioid-addiction Source: FDA website
Drug Warning 04-23-20
Hydroxychloroquine and chloroquine
The Food and Drug Administration (FDA) is reminding health care providers and consumers that hydroxychloroquine and chloroquine should not be used inappropriately to treat non-hospitalized patients for coronavirus disease (COVID-19) or to prevent the disease. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/hydroxychloroquine-or-chloroquine-covid-19-drug-safety-communication-fda-cautions-against-use Source: FDA website
Drug Warning 04-24-20
Ongentys
The Food and Drug Administration (FDA) approved Ongentys® (opicapone capsules) as add-on treatment for individuals with Parkinson's disease experiencing "off" episodes. Source: FDA website
New Drug 04-24-20
MenQuadfi
The Food and Drug Administration (FDA) approved MenQuadfiTM (meningococcal groups A, C, Y, W conjugate vaccine injection) for the prevention of invasive meningococcal disease in persons 2 years of age and older. Source: FDA website
New Formulation 04-24-20
Jublia
The Food and Drug Administration (FDA) approved Jublia® (efinaconazole topical solution) for the treatment of onychomycosis in children six years and older. Source: FDA website
Expanded Indication 04-26-20
Zejula
The Food and Drug Administration (FDA) approved Zejula® (niraparib capsules) for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. Source: FDA website
Expanded Indication 04-29-20
Milprosa
The Food and Drug Administration (FDA) approved MilprosaTM (progesterone vaginal system) to support embryo implantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology treatment program for infertile women up to and including 34 years of age. Source: FDA website
New Formulation 04-29-20
Darzalex Faspro
The Food and Drug Administration (FDA) approved Darzalex FasproTM (daratumumab/hyaluronidase-fihj subcutaneous injection) for adults with newly diagnosed or relapsed/refractory multiple myeloma. Source: FDA website
New Formulation 05-01-20
Fensolvi
The Food and Drug Administration (FDA) approved Fensolvi® (leuprolide acetate sustained release subcutaneous injection) for the treatment of pediatric individuals 2 years of age and older with central precocious puberty. Source: FDA website
New Formulation 05-01-20
Farxiga
The Food and Drug Administration (FDA) approved Farxiga® (dapagliflozin tablets) to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D). Source: FDA website
New Indication 05-05-20
Elyxyb
The Food and Drug Administration (FDA) approved Elyxyb (celecoxib oral solution) for acute treatment of migraine with or without aura in adults. Source: FDA website
New Formulation 05-05-20
Tabrecta
The Food and Drug Administration (FDA) approved TabrectaTM (capmatinib tablets) for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. Source: FDA website
New Formulation 05-06-20
Lynparza
The Food and Drug Administration (FDA) approved Lynparza® (olaparib tablets) for first-line maintenance treatment with bevacizumab for homologous recombination deficiency (HRD)-positive advanced ovarian cancer. Source: FDA website
Expanded Indication 05-08-20
Retevmo
The Food and Drug Administration (FDA) approved RetevmoTM (selpercatinib capsules) for adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC), adult and pediatric individuals 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, and for adult and pediatric individuals 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Source: FDA website
New Drug 05-08-20
Lactated Ringer's
ICU Medical announced a voluntary recall of one lot of Lactated Ringer’s injection due to the presence of particulate matter identified as iron oxide. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/icu-medical-issues-voluntary-nationwide-recall-lactated-ringers-injection-usp-due-presence Source: FDA website
Drug Recall 05-08-20
Finasteride Plus
MasterPharm announced a voluntary recall of one lot of Finasteride Plus 1.25 mg capsules due to presence of undeclared antihypertensive drug minoxidil. Finasteride Plus is a compounded drug for hair loss. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/masterpharm-llc-issues-voluntary-nationwide-recall-finasteride-plus-125mg-due-presence-undeclared Source: FDA website
Drug Recall 05-12-20
Pomalyst
The Food and Drug Administration (FDA) approved Pomalyst® (pomalidomide capsules) for treating adults with acquired immunodeficiency syndrome (AIDS)-related Kaposi sarcoma after failure of highly active antiretroviral therapy and Kaposi sarcoma in adults who are human immunodeficiency virus (HIV)-negative. Source: FDA website
New Indication 05-14-20
Rubraca
The Food and Drug Administration (FDA) approved Rubraca® (rucaparib tablets) for the treatment of adults with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Source: FDA website
New Indication 05-15-20
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) and Yervoy® (ipilimumab injection) as first-line treatment for individuals with metastatic non-small cell lung cancer (NSCLC) whose tumors express programmed cell death ligand 1 (PD-L1) (≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Source: FDA website
Expanded Indication 05-15-20
Tecentriq
The Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab injection) for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have high programmed cell death ligand 1 (PD-L1) expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of the tumor area [IC ≥ 10%]), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Source: FDA website
New Indication 05-18-20
Lynparza
The Food and Drug Administration (FDA) approved Lynparza® (olaparib tablets) for adults with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone. Source: FDA website
New Indication 05-19-20
Alunbrig
The Food and Drug Administration (FDA) approved Alunbrig® (brigatinib tablets) for adults with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. Source: FDA website
New Indication 05-22-20
Opdivo and Yervoy
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) plus Yervoy® (ipilimumab injection) given with two cycles of platinum-doublet chemotherapy for the first-line treatment of adults with metastatic or recurrent non-small cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Source: FDA website
New Indication 05-26-20
Dupixent
The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not considered suitable. Source: FDA website
Expanded Indication 05-26-20
Zosyn
The Food and Drug Administration (FDA) approved Zosyn® (piperacillin/tazobactam injection) for the treatment of nosocomial pneumonia in individuals 2 months and older. Source: FDA website
Expanded Indication 05-26-20
Kynmobi
The Food and Drug Administration (FDA) approved KynmobiTM (apomorphine sublingual film) for the acute, intermittent treatment of OFF episodes in individuals with Parkinson’s disease. Source: FDA website
New Formulation 05-22-20
Ferriprox
The Food and Drug Administration (FDA) approved Ferriprox® (deferiprone tablets) for the treatment of transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. There are 2 new 1,000 mg tablet formulations with different dosage frequencies (twice daily and three times daily). Source: FDA website
New Formulation 05-22-20
Artesunate
The Food and Drug Administration (FDA) approved Artesunate injection to treat severe malaria in adult and pediatric individuals. Source: FDA website
New Formulation 05-26-20
VESIcare LS
The Food and Drug Administration (FDA) approved VESIcare LSTM (solifenacin oral suspension) for the treatment of neurogenic detrusor overactivity (NDO), a form of bladder dysfunction related to neurological impairment, in children ages two years and older. Source: FDA website
New Formulation 05-26-20
Impeklo
The Food and Drug Administration (FDA) approved ImpekloTM (clobetasol propionate topical lotion for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in individuals 18 years of age and older. Source: FDA website
New Formulation 05-19-20
Sirturo
The Food and Drug Administration (FDA) approved Sirturo® (bedaquiline 20 mg tablets) for the treatment of pulmonary multi-drug resistant tuberculosis as part of combination therapy in individuals 5 to 12 years of age and weighing at least 15 kg. Source: FDA website
New Formulation 05-27-20
Phexxi
The Food and Drug Administration (FDA) approved PhexxiTM (lactic acid/citric acid/potassium bitartrate vaginal gel for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. Source: FDA website
New Formulation 05-22-20
Qinlock
The Food and Drug Administration (FDA) approved QinlockTM (ripretinib tablets) the treatment of adults with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Source: FDA website
New Drug 05-15-20
NP Thyroid
Acella Pharmaceuticals announced a voluntary recall of certain lots of NP Thyroid tablets due to super potency. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/acella-pharmaceuticals-llc-issues-voluntary-nationwide-recall-certain-lots-np-thyroidr-thyroid Source: FDA website
Drug Recall 05-22-20
Metformin Hydrochloride Extended-Release
Apotex announced a voluntary recall of all lots of metformin hydrochloride extended-release 500 mg tablets after one lot was tested by the Food and Drug Administration (FDA) and showed N-Nitrosodimethylamine (NDMA) concentrations exceeding established levels. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended-release-tablets Source: FDA website
Drug Recall 05-29-20
Brilinta
The Food and Drug Administration (FDA) approved Brilinta® (ticagrelor tablets) to reduce the risk of a first myocardial infarction (MI) or stroke in individuals with coronary artery disease (CAD) at high risk for such events. Source: FDA website
New Indication 05-28-20
Tecentriq
The Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab injection) plus bevacizumab to treat individuals with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. Source: FDA website
New Indication 05-29-20
Cyramza
The Food and Drug Administration (FDA) approved Cyramza® (ramucirumab injection) in combination with erlotinib for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. Source: FDA website
New Indication 05-29-20
Taltz
The Food and Drug Administration (FDA) approved Taltz® (ixekizumab injection for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA) in individuals with objective signs of inflammation. Source: FDA website
New Indication 05-29-20
Zilxi
The Food and Drug Administration (FDA) approved ZilxiTM (minocycline topical foam) for the treatment of inflammatory lesions of rosacea in adults. Source: FDA website
New Formulation 05-28-20
Akynzeo
The Food and Drug Administration (FDA) approved Akynzeo® (fosnetupitant/palonosetron ready-to-dilute injection) for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy in adults, when given with dexamethasone. Source: FDA website
New Formulation 06-02-20
Oriahnn
The Food and Drug Administration (FDA) approved Oriahnn® (elagolix/estradiol/norethindrone acetate co-packaged capsules) for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. Source: FDA website
New Formulation 05-29-20
Amneal
Amneal announced a voluntary recall of all lots of metformin hydrochloride extended-release tablets 500 and 750 mg after seven lots were tested by the Food and Drug Administration (FDA) and showed N-Nitrosodimethylamine (NDMA) concentrations exceeding established levels. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended Source: FDA website
Drug Recall 06-02-20
Apotex
Apotex announced a voluntary recall of all lots of metformin hydrochloride extended-release 500 mg tablets after one lot was tested by the Food and Drug Administration (FDA) and showed N-Nitrosodimethylamine (NDMA) concentrations exceeding established levels. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended-release-tablets Source: FDA website
Drug Recall 05-28-20
Epinephrine auto-injectors
The Food and Drug Administration (FDA) alerted consumers, caregivers, and health care providers to immediately inspect certain lots of Amneal and Impax epinephrine auto-injectors 0.3 mg to ensure the yellow “stop collar” in the device is present. If the auto-injector is missing the yellow “stop collar” component, the device has the potential safety risk of delivering a double dose of epinephrine. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/epinephrine-auto-injector-devices-amneal-and-impax-cder-alert-fda-alerts-patients-and-health-care Source: FDA website
Drug Warning 06-01-20
Recarbrio
The Food and Drug Administration (FDA) approved RecarbrioTM (imipenem/cilastatin/relebactam injection) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in individuals 18 years of age and older. Source: FDA website
New Indication 06-04-20
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for individuals with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. Source: FDA website
New Indication 06-10-20
Semglee
The Food and Drug Administration (FDA) approved SemgleeTM (insulin glargine injection) to control high blood sugar in adults with type 2 diabetes and adult and pediatric individuals with type 1 diabetes. Source: FDA website
New Formulation 06-11-20
Uplizna
The Food and Drug Administration (FDA) approved UpliznaTM (inebilizumab-cdon injection) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody (individuals who are anti-aquaporin-4 or AQP4 antibody positive). Source: FDA website
New Drug 06-11-20
Teva
Teva announced a voluntary recall of fourteen lots of metformin hydrochloride extended-release 500 and 750 mg tablets due to the detection of N-Nitrosodimethylamine (NDMA) concentrations in excess of established levels. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-pharmaceuticals-usa-inc-initiates-voluntary-nationwide-recall-metformin-hydrochloride-extended Source: FDA website
Drug Recall 06-05-20
Marksans Pharma
Marksans Pharma announced a voluntary recall of one lot of metformin hydrochloride extended-release 500 mg tablets after a Food and Drug Administration (FDA) analysis found the product to contain N-Nitrosodimethylamine (NDMA) concentrations exceeding established levels. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/marksans-pharma-limited-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended-release Source: FDA website
Drug Recall 06-05-20
Lupin Pharmaceuticals
Lupin Pharmaceuticals announced a voluntary recall of one lot of metformin hydrochloride extended-release 500 mg tablets after a Food and Drug Administration (FDA) analysis found the product to contain N-Nitrosodimethylamine (NDMA) concentrations exceeding established levels. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntarily-nationwide-recall-one-lot-metformin-hydrochloride Source: FDA website
Drug Recall 06-11-20
Gardasil 9
The Food and Drug Administration (FDA) approved Gardasil® 9 (human papillomavirus 9-valent vaccine injection) for the prevention of oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58. Source: FDA website
New Indication 06-12-20
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) as monotherapy for the treatment of adult and pediatric individuals with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by a Food and Drug Administration (FDA)-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. Source: FDA website
New Indication 06-16-20
Ilaris
The Food and Drug Administration (FDA) approved Ilaris® (canakinumab injection) for the treatment of Active Still’s disease, including Adult-Onset Still’s Disease (AOSD). Source: FDA website
New Indication 06-16-20
Cosentyx
The Food and Drug Administration (FDA) approved Cosentyx® (secukinumab injection) for the treatment of active non-radiographic axial spondyloarthritis. Source: FDA website
New Indication 06-16-20
Crysvita
The Food and Drug Administration (FDA) approved Crysvita® (burosumab-twza injection) to treat individuals aged 2 years and older with tumor-induced osteomalacia (TIO). Source: FDA website
New Indication 06-18-20
Tazverik
The Food and Drug Administration (FDA) approved TazverikTM (tazemetostat tablets) for adults with relapsed or refractory follicular lymphoma whose tumors are positive for an enhancer of zeste homolog 2 (EZH2) mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for adults with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. Source: FDA website
New Indication 06-18-20
Erelzi
The Food and Drug Administration (FDA) approved ErelziTM (etanercept-szzs injection) for the treatment of individuals ages 4 to 17 years with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Source: FDA website
Expanded Indication 06-11-20
Mylotarg
The Food and Drug Administration (FDA) approved MylotargTM (gemtuzumab ozogamicin injection) for newly diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric individuals 1 month and older. Source: FDA website
Expanded Indication 06-16-20
Tivicay
The Food and Drug Administration (FDA) approved Tivicay® (dolutegravir tablets) to treat human immunodeficiency virus 1 (HIV)-1 infection in pediatric individuals at least four weeks old and weighing at least 3 kg (6.61 pounds) in combination with other antiretroviral treatments. Source: FDA website
Expanded Indication 06-12-20
Tivicay PD
The Food and Drug Administration (FDA) approved Tivicay® PD (dolutegravir tablets for suspension) to treat human immunodeficiency virus 1 (HIV)-1 infection in pediatric individuals at least four weeks old and weighing at least 3 kg (6.61 pounds) in combination with other antiretroviral treatments. Source: FDA website
New Formulation 06-12-20
Lyumjev
The Food and Drug Administration (FDA) approved LyumjevTM (insulin lispro-aabc rapid-acting injection) to improve glycemic control in adults with type 1 and type 2 diabetes. Source: FDA website
New Formulation 06-15-20
Zepzelca
The Food and Drug Administration (FDA) approved ZepzelcaTM (lurbinectedin injection) for the treatment of adults with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Source: FDA website
New Drug 06-15-20
Remdesivir
The Food and Drug Administration (FDA) is warning health care providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/remdesivir-gilead-sciences-fda-warns-newly-discovered-potential-drug-interaction-may-reduce Source: FDA website
Drug Warning 06-15-20
Xpovio
The Food and Drug Administration (FDA) approved Xpovio® (selinexor tablets) for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. Source: FDA website
New Indication 06-22-20
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for individuals with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. Source: FDA website
New Indication 06-24-20
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) the first-line treatment of individuals with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. Source: FDA website
New Indication 06-29-20
Bavencio
The Food and Drug Administration (FDA) approved Bavencio® (avelumab injection) for first-line maintenance treatment in individuals with locally advanced or metastatic urothelial carcinoma. Source: FDA website
New Indication 06-30-20
Lialda
The Food and Drug Administration (FDA) approved Lialda® (mesalamine tablets) for the treatment of mildly to moderately active ulcerative colitis in pediatric individuals weighing at least 24 kg. Source: FDA website
Expanded Indication 06-26-20
Sivextro
The Food and Drug Administration (FDA) approved Sivextro® (tedizolid injection and tablets) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric individuals from 12 years to less than 18 years of age. Source: FDA website
Expanded Indication 06-19-20
Gimoti
The Food and Drug Administration (FDA) approved GimotiTM (metoclopramide nasal spray) for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Source: FDA website
New Formulation 06-19-20
Mycapssa
The Food and Drug Administration (FDA) approved Mycapssa® (octreotide capsules) for the long-term maintenance treatment of individuals with acromegaly who have responded to and tolerated octreotide or lanreotide. Source: FDA website
New Formulation 06-26-20
Fintepla
The Food and Drug Administration (FDA) approved Fintepla® (fenfluramine oral solution) for the treatment of Dravet syndrome in individuals 2 years of age and older. Source: FDA website
New Formulation 06-26-20
Phesgo
The Food and Drug Administration (FDA) approved PhesgoTM (pertuzumab/trastuzumab/hyaluronidase-zzxf subcutaneous injection) for use in combination with chemotherapy as neoadjuvant treatment of individuals with human epidermal growth factor receptor 2 (HER2)-positive, locally advanced, inflammatory, or early stage breast cancer as part of a complete treatment regimen for early breast cancer or as adjuvant treatment of individuals with HER2-positive early breast cancer at high risk of recurrence. Also approved for use in combination with docetaxel for treatment of individuals with HER2- positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. Source: FDA website
New Formulation 06-29-20
Dupixent
The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) pre-filled pen formulation for all indications in individuals aged 12 years and older, which includes use in certain individuals with atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP), for at-home administration. Source: FDA website
New Formulation 06-19-20
Dojolvi
The Food and Drug Administration (FDA) approved DojolviTM (triheptanoin oral liquid) as a source of calories and fatty acids for the treatment of pediatric and adult individuals with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD). Source: FDA website
New Drug 06-30-20
Botox
The Food and Drug Administration (FDA) approved Botox® (onabotulinumtoxinA injection) for the treatment of spasticity in pediatric individuals 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy. Source: FDA website
Expanded Indication 07-08-20
Dysport
The Food and Drug Administration (FDA) approved Dysport® (abobotulinumtoxinA injection) for the treatment of spasticity in pediatric individuals 2 years of age and older, including those with upper and lower limb spasticity caused by cerebral palsy. Source: FDA website
Expanded Indication 07-08-20
Tremfya
The Food and Drug Administration (FDA) approved Tremfya® (guselkumab injection) for the treatment of adults with active psoriatic arthritis. Source: FDA website
New Indication 07-13-20
Tralement
The Food and Drug Administration (FDA) approved TralementTM (trace elements injection) in adult and pediatric individuals weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Source: FDA website
New Formulation 07-02-20
Qwo
The Food and Drug Administration (FDA) approved QwoTM (collagenase clostridium histolyticum-aaes injection) for the treatment of moderate to severe cellulite in the buttocks of adult women. Source: FDA website
New Formulation
Upneeq
The Food and Drug Administration (FDA) approved UpneeqTM (oxymetazoline hydrochloride ophthalmic solution) for the treatment of acquired blepharoptosis (droopy eyelid) in adults. Source: FDA website
New Formulation 07-08-20
Inqovi
The Food and Drug Administration (FDA) approved Inqovi® (decitabine/cedazuridine injection) for the treatment of adults with certain myelodysplastic syndromes (MDS). Source: FDA website
New Drug 07-07-20
Byfavo
The Food and Drug Administration (FDA) approved ByfavoTM (remimazolam injection) for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. Source: FDA website
New Drug 07-02-20
Rukobia
The Food and Drug Administration (FDA) approved Rukobia (fostemsavir extended-release tablets) in combination with other antiretroviral(s), for the treatment of human immunodeficiency virus (HIV)-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations. Source: FDA website
New Drug 07-02-20
Daptomycin
Mylan announced a voluntary recall of one lot of daptomycin for injection 500 mg/vial due to the presence of particulate matter. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-initiates-voluntary-nationwide-recall-one-lot-daptomycin-injection-due-presence-particulate Source: FDA website
Drug Recall 07-07-20
Lupin Pharmaceuticals
Lupin Pharmaceuticals announced a voluntary recall of all batches of metformin hydrochloride extended-release 500 mg and 1000 mg tablets due to certain batches exceeding the acceptable limit for the impurity N-Nitrosodimethylamine (NDMA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lupin-pharmaceuticals-inc-issues-voluntarily-nationwide-recall-metformin-hydrochloride-extended Source: FDA website
Drug Recall 07-08-20
Granules Pharmaceuticals
Granules Pharmaceuticals announced a voluntary recall of twelve lots of metformin hydrochloride extended-release 750 mg tablets due to the detection of N-Nitrosodimethylamine (NDMA) levels above the acceptable limit. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/granules-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended Source: FDA website
Drug Recall 07-06-20
Metformin Extended-Release
The Food and Drug Administration (FDA) is alerting consumers and health care providers to several voluntary recalls of extended release metformin by certain companies. The companies are recalling metformin due to the possibility they could contain nitrosodimethylamine (NDMA) above the acceptable intake limit. Contact your healthcare provider with questions. More details and a list of companies may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin?utm_campaign=Several%20Companies%20Voluntarily%20Recall%20Extended%20Release%20Metformin&utm_medium=email&utm_source=Eloqua Source: FDA website
Drug Recall 07-13-20
Qutenza
The Food and Drug Administration (FDA) approved Qutenza® (capsaicin topical patch) for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet. Source: FDA website
New Indication 07-17-20
Wynzora
The Food and Drug Administration (FDA) approved Wynzora® (calcipotriene/betamethasone dipropionate topical cream) for once daily treatment of plaque psoriasis in adults 18 years of age or older. Source: FDA website
New Formulation 07-20-20
Xywav
The Food and Drug Administration (FDA) approved XywavTM (calcium/magnesium/potassium/sodium oxybates oral solution) for cataplexy or excessive daytime sleepiness associated with narcolepsy. Xywav contains 92% less sodium per dose than currently available sodium oxybate formulation. Source: FDA website
New Formulation 07-21-20
Breztri Aerosphere
The Food and Drug Administration (FDA) approved Breztri AerosphereTM (budesonide/glycopyrrolate/formoterol fumarate oral inhalation) for the maintenance treatment of individuals with chronic obstructive pulmonary disease (COPD). Source: FDA website
New Formulation 07-23-20
Xeglyze
The Food and Drug Administration (FDA) approved XeglyzeTM (abametapir topical lotion) for the treatment of head lice infestation in individuals 6 months of age and older. Source: FDA website
New Drug 07-24-20
Tecartus
The Food and Drug Administration (FDA) approved TecartusTM (brexucabtagene autoleucel intravenous infusion) for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL). Source: FDA website
New Drug 07-24-20
Dexmedetomidine hydrochloride
Fresenius Kabi announced a voluntary recall of two lots of dexmedetomidine hydrochloride injection due to the possible presence of trace amounts of lidocaine. Contact your health care provider with questions More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-two-lots-dexmedetomidine-hydrochloride-injection Source: FDA website
Drug Recall 07-23-20
Opioid pain relievers and drugs to treat opioid use disorder
The Food and Drug Administration (FDA) is requiring drug manufacturers for all opioid pain relievers and drugs to treat opioid use disorder to add new recommendations about naloxone to the prescribing information. Contact your health care provider with questions More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/opioid-pain-relievers-or-medicines-treat-opioid-use-disorder-medwatch-safety-alert-fda-recommends Source: FDA website
Drug Warning 07-23-20
Stelara
The Food and Drug Administration (FDA) approved Stelara® (ustekinumab injection) for the treatment of pediatric individuals 6 to 11 years of age with moderate to severe plaque psoriasis. Source: FDA website
New Indication 07-29-20
Tecentriq
The Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab injection) in combination with Cotellic® (cobimetinib tablets) and Zelboraf® (vemurafenib tablets) for the treatment of BRAF V600 mutation-positive advanced melanoma. Source: FDA website
New Indication 07-30-20
Epidiolex
The Food and Drug Administration (FDA) approved Epidiolex® (cannabidiol oral solution) for the treatment of seizures associated with tuberous sclerosis complex (TSC) in individuals one year of age and older. Source: FDA website
New Indication 07-31-20
Spravato
The Food and Drug Administration (FDA) approved Spravato® (esketamine nasal spray) with an oral antidepressant to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. Source: FDA website
Expanded Indication 07-31-20
Prezcobix
The Food and Drug Administration (FDA) approved Prezcobix® (cobicistat/darunavir tablets) for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus 1 (HIV-1) infection in treatment naïve and treatment-experienced pediatric individuals weighing at least 40 kg with no darunavir resistance-associated substitutions. Source: FDA website
Expanded Indication 07-31-20
Evotaz
The Food and Drug Administration (FDA) approved Evotaz® (atazanavir sulfate/cobicistat tablets) for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus 1 (HIV-1) infection in pediatric individuals weighing at least 35 kg. Source: FDA website
Expanded Indication 07-31-20
Suprep
The Food and Drug Administration (FDA) approved Suprep® (sodium sulfate/potassium sulfate/magnesium sulfate oral solution) for cleansing of the colon in preparation for colonoscopy in pediatric individuals 12 years of age and older. Source: FDA website
Expanded Indication 08-05-20
Dovato
The Food and Drug Administration (FDA) approved Dovato (dolutegravir/lamivudine tablets) for the treatment of human immunodeficiency virus 1 (HIV-1) infection in individuals who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure. Source: FDA website
Expanded Indication 08-06-20
Xtandi
The Food and Drug Administration (FDA) approved Xtandi® (enzalutamide tablets) for the treatment of individuals with castration-resistant prostate cancer or metastatic castration-sensitive prostate cancer. Source: FDA website
New Formulation 08-04-20
Monjuvi
The Food and Drug Administration (FDA) approved Monjuvi® (tafasitamab-cxix injection) in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). Source: FDA website
New Drug 07-31-20
Blenrep
The Food and Drug Administration (FDA) approved Blenrep (belantamab mafodotin-blmf injection) for adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. Source: FDA website
New Drug 08-05-20
Lampit
The Food and Drug Administration (FDA) approved Lampit® (nifurtimox tablets) for the treatment of Chagas disease in children. Source: FDA website
New Drug 08-06-20
Evrysdi
The Food and Drug Administration (FDA) approved EvrysdiTM (risdiplam oral solution) for the treatment of spinal muscular atrophy (SMA) in individuals 2 months of age and older. Source: FDA website
New Drug 08-07-20
DDAVP, Desmopressin Acetate, and Stimate
Ferring Pharmaceuticals announced a voluntary recall of all lots of DDAVP® (desmopressin nasal spray) 10 mcg/0.1 mL, Desmopressin Acetate nasal spray 10 mcg/0.1 mL, and Stimate® (desmopressin nasal spray) 1.5 mg/mL. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ferring-us-issues-voluntary-nationwide-recall-ddavpr-nasal-spray-10-mcg01ml-desmopressin-acetate Source: FDA website
Drug Recall 08-06-20
Darzalex
The Food and Drug Administration (FDA) approved Darzalex® (daratumumab injection) in combination with Kyprolis® (carfilzomib injection) and dexamethasone for the treatment of adults with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy. Source: FDA website
Expanded Indication 08-20-20
Xyntha
The Food and Drug Administration (FDA) approved Xyntha® (antihemophilic factor, recombinant injection) for routine prophylaxis to reduce the frequency of bleeding episodes in individuals with hemophilia A. Source: FDA website
New Indication 07-29-20
Xeomin
The Food and Drug Administration (FDA) approved Xeomin® (incobotulinumtoxinA injection) for the treatment of individuals 2 years and older with upper limb spasticity, excluding spasticity caused by cerebral palsy. Source: FDA website
New Indication 08-19-20
Cystadrops
The Food and Drug Administration (FDA) approved Cystadrops® (cysteamine ophthalmic solution) for the treatment of corneal cystine crystal deposits in adults and children with cystinosis. Source: FDA website
New Formulation 08-19-20
Olinvyk
The Food and Drug Administration (FDA) approved OlinvykTM (oliceridine injection) for the management of acute pain severe enough to require intravenous opioid analgesic and for whom alternatives are inadequate in adults. Source: FDA website
New Drug 08-07-20
Viltepso
The Food and Drug Administration (FDA) approved ViltepsoTM (viltolarsen injection) for the treatment of Duchenne muscular dystrophy (DMD) in individuals who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. Source: FDA website
New Drug 08-12-20
Enspryng
The Food and Drug Administration (FDA) approved EnspryngTM (satralizumab-mwge injection) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive. Source: FDA website
New Drug 08-14-20
Kesimpta
The Food and Drug Administration (FDA) approved Kesimpta® (ofatumumab injection) for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Source: FDA website
New Drug 08-20-20
Bayshore Pharmaceuticals
Bayshore Pharmaceuticals announced a voluntary recall of one lot of metformin hydrochloride extended-release 500 mg tablets and one lot of metformin hydrochloride extended-release 750 mg tablets due to the detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable daily limit. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayshore-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended Source: FDA website
Drug Recall 08-20-20
Mirena
The Food and Drug Administration (FDA) approved Mirena® (levonorgestrel intrauterine device) for prevention of pregnancy for up to 6 years. Source: FDA website
Expanded Indication 08-20-20
Ultravate
The Food and Drug Administration (FDA) approved Ultravate® (halobetasol propionate lotion) for the treatment of plaque psoriasis in pediatric individuals 12 years of age and older. Source: FDA website
Expanded Indication 08-27-20
Onureg
The Food and Drug Administration (FDA) approved Onureg® (azacitidine tablets) for continued treatment of adults with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. Source: FDA website
New Formulation 09-01-20
Xaracoll
The Food and Drug Administration (FDA) approved Xaracoll® (bupivacaine implant) for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair. Source: FDA website
New Formulation 08-28-20
Sogroya
The Food and Drug Administration (FDA) approved Sogroya® (somapacitan injection) for once weekly treatment of adult growth hormone deficiency. Source: FDA website
New Drug 08-28-20
Winlevi
The Food and Drug Administration (FDA) approved Winlevi® (clascoterone cream) for the treatment of acne vulgaris in individuals 12 years and older. Source: FDA website
New Drug 08-26-20
Mylan
Mylan announced a voluntary recall of four lots of amiodarone injection and tranexamic acid injection due to carton label mix-up. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-initiates-voluntary-nationwide-recall-four-lots-amiodarone-hcl-injection-usp-and-tranexamic Source: FDA website
Drug Recall 08-28-20
Invokana, Invokamet, Invokamet XR
Based on Food and Drug Administration (FDA) review of new data from three clinical trials, the boxed warning about amputation risk from the diabetes medicine canagliflozin (Invokana® , Invokamet® , Invokamet® XR) was removed from the prescribing information. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/invokana-invokamet-invokamet-xr-canagliflozin-medwatch-safety-alert-boxed-warning-about-risk-leg-and Source: FDA website
Drug Warning 08-26-20
Trelegy Ellipta
The Food and Drug Administration (FDA) approved Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol oral inhalation) for the treatment of asthma in individuals aged 18 years and older. Source: FDA website
New Indication 09-09-20
Qdolo
The Food and Drug Administration (FDA) approved QdoloTM (tramadol oral solution) for adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Source: FDA website
New Formulation 09-01-20
Gavreto
The Food and Drug Administration (FDA) approved GavretoTM (pralsetinib capsules) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. Source: FDA source
New Drug 09-04-20
RLC Labs
RLC Labs announced a voluntary recall of 483 lots of Nature-Thyroid® and WP Thyroid® (thyroid tablets) in all strengths within current expiry due to sub-potency. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/rlc-labs-inc-issues-voluntary-nationwide-recall-all-lots-nature-throidr-and-wp-thyroidr-current Source: FDA website
Drug Recall 09-06-20
Tecentriq
The Food and Drug Administration (FDA) alerted health care providers and consumers that a clinical trial studying the use of Tecentriq® (atezolizumab injection) and paclitaxel in individuals with previously untreated inoperable locally advanced or metastatic triple negative breast cancer (mTNBC) showed the drug combination did not work to treat the disease. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-issues-alert-about-efficacy-and-potential-safety-concerns-atezolizumab-combination-paclitaxel Source: FDA website
Drug Warning 09-08-20
Eraxis
The Food and Drug Administration (FDA) approved EraxisTM (anidulafungin injection) in pediatric individuals one month and older for the treatment of candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis). Source: FDA website
Expanded Indication 09-22-20
Kalydeco
The Food and Drug Administration (FDA) approved Kalydeco® (ivacaftor tablets and oral granules) for use in children with cystic fibrosis (CF) ages four months to less than six months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to ivacaftor based on clinical and/or in vitro assay data. Source: FDA website
Expanded Indication 09-24-20
Acella Pharmaceuticals
Acella Pharmaceuticals announced a voluntary recall of one lot of 15 mg and one lot of 120 mg NP Thyroid® (thyroid tablets) due to sub potency. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/acella-pharmaceuticals-llc-issues-voluntary-nationwide-recall-two-lots-np-thyroidr-thyroid-tablets Source: FDA website
Drug Recall 09-18-20
Albuterol
Perrigo announced a voluntary recall of all unexpired albuterol sulfate inhalers due to possible clogging of the inhaler. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-perrigos-voluntary-albuterol-inhaler-recall#:~:text=%5B9%2F21%2F2020%5D,clogging%20of%20the%20inhaler%20resulting Source: FDA website
Drug Recall 09-21-20
Riomet ER
Sun Pharmaceutical announced a voluntary recall of one lot of Riomet ERTM (metformin extended-release oral suspension) due to levels of N-Nitrosodimethylamine (NDMA) found to be above the allowable daily limit established by the Food and Drug Administration (FDA). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sun-pharmaceutical-industries-inc-issues-voluntary-nationwide-recall-riomet-ertm-metformin Source: FDA website
Drug Recall 09-23-20
Diphenhydramine
The Food and Drug Administration (FDA) is warning that taking higher than recommended doses of over-the-counter (OTC) allergy medicine diphenhydramine can lead to serious heart problems, seizures, coma, or death. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/benadryl-diphenhydramine-drug-safety-communication-serious-problems-high-doses-allergy-medicine Source: FDA website
Drug Warning 09-24-20
Dental Amalgam
The Food and Drug Administration (FDA) is providing recommendations about the use of dental amalgam in people who may be at greater risk to the potential adverse effects of mercury exposure. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/medical-devices/safety-communications/recommendations-about-use-dental-amalgam-certain-high-risk-populations-fda-safety-communication Source: FDA website
Drug Warning 09-24-20
Benzodiazepines
The Food and Drug Administration (FDA) is requiring an updated Boxed Warning for all benzodiazepine medications to describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions consistently across all the medicines in the class. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/benzodiazepine-drug-class-drug-safety-communication-boxed-warning-updated-improve-safe-use Source: FDA website
Drug Warning 09-23-20
Nucala
The Food and Drug Administration (FDA) approved Nucala® (mepolizumab injection) for the treatment of adult and pediatric individuals aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without an identifiable non-hematologic secondary cause. Source: FDA website
New Indication 09-25-20
Fetroja
The Food and Drug Administration (FDA) approved Fetroja® (cefiderocol injection) for the treatment of adults with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible Gram-negative microorganisms. Source: FDA website
New Indication 09-25-20
Xeljanz
The Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib tablets and oral solution) for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). Source: FDA website
New Indication 09-25-20
Simponi Aria
The Food and Drug Administration (FDA) approved Simponi Aria® (golimumab injection) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) and active psoriatic arthritis (PsA). Source: FDA website
New Indication 09-29-20
Opdivo and Yervoy
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) and Yervoy® (ipilimumab injection) for the treatment of previously untreated unresectable malignant pleural mesothelioma. Source: FDA website
New Indication 10-02-20
Haegarda
The Food and Drug Administration (FDA) approved Haegarda® (C1 esterase inhibitor injection) for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in individuals 6 years of age and older. Source: FDA website
Expanded Indication 09-28-20
Alkindi Sprinkle
The Food and Drug Administration (FDA) approved Alkindi® Sprinkle (hydrocortisone oral granules) as replacement therapy for adrenocortical insufficiency (AI) in children under 17 years of age. Source: FDA website
New Formulation 09-29-20
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of adults with relapsed or refractory classical Hodgkin lymphoma (cHL). Source: FDA website
Expanded Indication 10-14-20
Wakix
The Food and Drug Administration (FDA) approved Wakix® (pitolisant tablets) for the treatment of cataplexy in adults with narcolepsy. Source: FDA website
Expanded Indication 10-13-20
Inmazeb
The Food and Drug Administration (FDA) approved InmazebTM (atoltivimab/maftivimab/odesivimab-ebgn injection) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric individuals, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection. Source: FDA website
New Drug 10-14-20
Marksans Pharma
Marksans Pharma announced an expanded voluntary recall to include an additional 76 lots of unexpired lots of metformin hydrochloride extended-release 500 and 750 mg tablets due to levels of N-Nitrosodimethylamine (NDMA) exceeding the acceptable daily limit in some lots. Contact your healthcare provider with questions. More detail may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/marksans-pharma-limited-issues-expansion-voluntary-nationwide-recall-metformin-hydrochloride Source: FDA website
Drug Recall 10-05-20
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
The Food and Drug Administration (FDA) is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. Contact your healthcare provider with questions. More detail may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/nonsteroidal-anti-inflammatory-drugs-nsaids-drug-safety-communication-avoid-use-nsaids-pregnancy-20 Source: FDA website
Drug Warning 10-15-20
Self-Collection of Nasal Samples
The Food and Drug Administration (FDA) recommends that health care providers give clear, step-by-step instructions to individuals who, in a health care setting, are self-collecting nasal samples for SARS-CoV-2 testing. Contact your healthcare provider with questions. More detail may be viewed at: https://www.fda.gov/medical-devices/letters-health-care-providers/recommendations-providing-clear-instructions-patients-who-self-collect-anterior-nares-nasal-sample Source: FDA website
Drug Warning 10-13-20
Esomeprazole orally disintegrating tablet
The Food and Drug Administration (FDA) approved Esomeprazole orally disintegrating delayed-release tablets for the treatment of frequent heartburn (occurs 2 or more days a week) in adults (18 years of age and older). Source: FDA website
New Formulation 10-20-20
Eysuvis
The Food and Drug Administration (FDA) approved EysuvisTM (loteprednol etabonate ophthalmic suspension) for the short-term treatment of the signs and symptoms of dry eye disease. Source: FDA website
New Formulation 10-27-20
Veklury
TThe Food and Drug Administration (FDA) approved Veklury® (remdesivir injection) for the treatment of COVID-19 requiring hospitalization in adult and pediatric individuals (12 years of age and older and weighing at least 40 kg). Source: FDA website
New Drug 10-22-20
Sklice
The Food and Drug Administration (FDA) approved Sklice® (ivermectin topical lotion) for over-the-counter (OTC) treatment of head lice infestation in individuals 6 months of age and older. Source: FDA website
Rx to Over-the-Counter Switch 10-27-20
Selzentry
The Food and Drug Administration (FDA) approved Selzentry® (maraviroc tablets and oral solution) to include the treatment of human immunodeficiency virus (HIV) infection in pediatric individuals weighing at least 2 kg. Source: FDA website
New Indication 10-30-20
Totect
The Food and Drug Administration (FDA) approved Totect® (dexrazoxane injection) for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m² and who will continue to receive doxorubicin therapy to maintain tumor control. Source: FDA website
New Indication 11-02-20
Brilinta
The Food and Drug Administration (FDA) approved Brilinta® (ticagrelor tablets) to reduce the risk of stroke in individuals with an acute ischemic stroke or high-risk transient ischemic attack. Source: FDA website
New Indication 11-05-20
Bronchitol
The Food and Drug Administration (FDA) approved Bronchitol® (mannitol inhalation powder) as add-on maintenance therapy to improve pulmonary function in adults 18 years of age and older with cystic fibrosis (CF). Source: FDA website
New Formulation 10-30-20
Metformin extended-release tablets 500 mg
Nostrum Laboratories announced a voluntary recall of two lots of metformin extended-release tablets 500 mg due to N-Nitrosodimethylamine (NDMA) content above the acceptable daily intake (ADI) limit. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nostrum-laboratories-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0 Source: FDA website
Drug Recall 11-04-20
Metformin extended-release tablets 750 mg
Nostrum Laboratories announced a voluntary recall of two lots of metformin extended-release tablets 750 mg due to N-Nitrosodimethylamine (NDMA) content above the acceptable daily intake (ADI) limit. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nostrum-laboratories-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets Source: FDA website
Drug Recall 11-04-20
Paroex
Sunstar Americas announced a voluntary recall of Paroex® (chlorhexidine gluconate oral rinse 0.12%) due to microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sunstar-americas-inc-issues-voluntary-nationwide-recall-paroexr-chlorhexidine-gluconate-oral-rinse Source: FDA website
Drug Recall 10-28-20
Sutab
The Food and Drug Administration (FDA) approved Sutab® (sodium sulfate/magnesium sulfate/potassium chloride tablets) for colonoscopy preparation. Source: FDA website
New Formulation 10-10-20
Sesquient
The Food and Drug Administration (FDA) approved SesquientTM (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric individuals. Source: FDA website
New Formulation 11-05-20
Labetalol hydrochloride in dextrose
The Food and Drug Administration (FDA) approved Labetalol hydrochloride in dextrose injection in severe hypertension to lower blood pressure. Source: FDA website
New Formulation 11-09-20
Lohxa
Lohxa LLC announced a voluntary recall of specific lots of chlorhexidine gluconate oral rinse 0.12% due to microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/lohxa-llc-issues-voluntary-nationwide-recall-chlorhexidine-gluconate-oral-rinse-usp-012-due Source: FDA website
Drug Recall 11-09-20
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for use in combination with chemotherapy to treat individuals with locally recurrent, unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 with a combined positive score (CPS) of 10 or greater. Source: FDA website
New Indication 11-13-20
Vimpat
The Food and Drug Administration (FDA) approved Vimpat® (lacosamide tablet, oral solution, and injection) as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in individuals four years of age and older. The injection is now also approved for the treatment of partial-onset seizures in individuals four years of age and older. Source: FDA website
New Indication 11-16-20
Zokinvy
The Food and Drug Administration (FDA) approved ZokinvyTM (lonafarnib capsule) to reduce the risk of death due to Hutchinson-Gilford progeria syndrome and for the treatment of certain processing-deficient progeroid laminopathies in individuals one year of age and older. Source: FDA website
New Drug 11-20-20
Dexmedetomidine hydrochloride
Fresenius Kabi announced a voluntary recall of one lot of dexmedetomidine HCL in 0.9% sodium chloride injection due to a trace amount of lidocaine present in the lot. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-single-lot-dexmedetomidine-hydrochloride-injection Source: FDA website
Drug Recall 11-20-20