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
Zeposia
The Food and Drug Administration (FDA) approved Zeposia® (ozanimod capsules) for the treatment of moderately to severely active ulcerative colitis (UC) in adults. Source: FDA website
New Indication 05-27-21
Zipsor
The Food and Drug Administration (FDA) approved Zipsor® (diclofenac potassium capsules) for relief of mild to moderate acute pain in pediatric individuals 12 years of age and older. Source: FDA website
Expanded Indication 05-25-21
Lorbrena
The Food and Drug Administration (FDA) approved Lorbrena® (lorlatinib tablets) for first-line treatment of individuals with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Source: FDA website
New Indication 03-03-21
Actemra
The Food and Drug Administration (FDA) approved Actemra® (tocilizumab subcutaneous injection) for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Source: FDA website
New Indication 03-04-21
Yervoy
The Food and Drug Administration (FDA) approved Yervoy® (ipilimumab injection) in combination with nivolumab for the treatment of adults with unresectable or metastatic melanoma. Source: FDA website
Expanded Indication 05-25-21
Yescarta
The Food and Drug Administration (FDA) approved Yescarta® (axicabtagene ciloleucel injection) for the treatment of adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Source: FDA website
New Indication 03-05-21
Flucelvax Quadrivalent
The Food and Drug Administration (FDA) approved Flucelvax® Quadrivalent (inactivated influenza vaccine injection) for active immunization in individuals 2 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. Source: FDA website
New Indication 03-05-21
Azstarys
The Food and Drug Administration (FDA) approved AzstarysTM (serdexmethylphenidate/dexmethylphenidate capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in individuals age six years and older. Source: FDA website
New Drug 03-02-21
Fotivda
The Food and Drug Administration (FDA) approved Fotivda® (tivozanib capsules) for the treatment of adults with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. Source: FDA website
New Drug 03-10-21
Spironolactone
Bryant Ranch Prepack announced a voluntary recall of 4 lots of spironolactone tablets due to mislabeling with the incorrect strength. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bryant-ranch-prepack-issues-voluntary-nationwide-recall-spironolactone-25-mg-and-50-mg-tablets-due Source: FDA website
Drug Recall 03-10-21
AvKARE
AvKare announced a voluntary recall of one lot of sildenafil 100 mg tablets and one lot of trazodone 100 mg tablets due to a product mix-up of the listed two separate products inadvertently packaged together during bottling. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avkare-issues-voluntary-nationwide-recall-sildenafil-100mg-tablets-and-trazodone-100mg-tablets-due Source: FDA website
Drug Recall 12-09-20
Camcevi
The Food and Drug Administration (FDA) approved Camcevi® (leuprolide mesylate subcutaneous injection depot) for the treatment of advanced prostate cancer. Source: FDA website
New Formulation 05-25-21
Myfembree
The Food and Drug Administration (FDA) approved Myfembree® (relugolix/estradiol/norethindrone acetate tablets) for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Source: FDA website
New Drug 05-26-21
Lumakras
The Food and Drug Administration (FDA) approved LumakrasTM (sotorasib tablets) for the treatment of adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. Source: FDA website
New Drug 05-28-21
Regenecare HA Hydrogel
MPM Medical announced a voluntary recall of one lot of Regenecare® HA Hydrogel (lidocaine topical) due to bacterial contamination. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mpm-medical-llc-issues-voluntary-nationwide-recall-regenecare-ha-hydrogel-due-burkholderia-cepecia Source: FDA website
Drug Recall 12-02-20
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
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
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
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
Anagrelide
Torrent Pharmaceuticals announced a voluntary recall of one lot of anagrelide capsules due to dissolution test failure. Contact your health care provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/torrent-pharmaceuticals-limited-issues-voluntary-nationwide-recall-anagrelide-capsules-usp-due Source: FDA website
Drug Recall 12-09-20
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
Nurtec ODT
The Food and Drug Administration (FDA) approved Nurtec® ODT (rimegepant orally disintegrating tablets) for the preventive treatment of episodic migraine in adults. Source: FDA website
New Indication 05-27-21
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
Saxenda
The Food and Drug Administration (FDA) approved Saxenda® (liraglutide injection) for chronic weight management among individuals aged 12 and older who are obese, as defined by specific body mass index (BMI) cut-offs for age and sex that correspond to a BMI 30 kg/m2 or higher for adults, and who weigh more than 60 kg (132 pounds). Saxenda is an adjunct to a reduced-calorie diet and greater physical activity. Source: FDA website
New Indication 12-04-20
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
Orladeyo
The Food and Drug Administration (FDA) approved Orladeyo™ (berotralstat capsule) as prophylaxis to prevent attacks of hereditary angioedema (HAE) in individuals 12 years and older. Source: FDA website
New Drug 12-03-20
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
Xofluza
The Food and Drug Administration (FDA) approved XofluzaTM (baloxavir marboxil tablets and oral granules) for post-exposure prevention of influenza in individuals 12 years of age and older after contact with an individual who has the flu. A new oral granule for mixing in water was also approved. Source: FDA website
New Indication and New Formulation 11-23-20
Gavreto
The Food and Drug Administration (FDA) approved GavretoTM (pralsetinib capsules) for adult and pediatric individuals 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy or RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Source: FDA website
New Indication 12-01-20
Xolair
The Food and Drug Administration (FDA) approved Xolair® (omalizumab subcutaneous injection) as add-on maintenance treatment of nasal polyps in adults with inadequate response to nasal corticosteroids. Source: FDA website
New Indication 11-30-20
Hetlioz and Hetlioz LQ
The Food and Drug Administration (FDA) approved Hetlioz® (tasimelteon capsules) and Hetlioz LQTM (tasimelteon oral suspension) for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in adults and children, respectively. Source: FDA website
New Indication and New Formulation 12-01-20
Thyquidity
The Food and Drug Administration (FDA) approved ThyquidityTM (levothyroxine oral solution) for replacement therapy in hypothyroidism and as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Source: FDA website
New Formulation 11-30-20
Oxlumo
The Food and Drug Administration (FDA) approved OxlumoTM (lumasiran subcutaneous injection) for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult individuals. Source: FDA website
New Drug 11-23-20
Imcivree
The Food and Drug Administration (FDA) approved Imcivree (setmelanotide subcutaneous injection) for chronic weight management in adult and pediatric individuals 6 years of age and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency, Source: FDA website
New Drug 11-25-20
Danyelza
The Food and Drug Administration (FDA) approved Danyelza® (naxitamab-gqgk intravenous injection) for the treatment of pediatric individuals 1 year of age and older and adults with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. Source: FDA website
New Drug 11-25-20
Fusion Health and Vitality
Fusion Health and Vitality announced a voluntary recall of all lots of Core Essential Nutrients and Immune Boost Sublingual Vitamin D3 due to unapproved use of a food additive. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fusion-health-and-vitality-issues-voluntary-nationwide-recall-core-essential-nutrients-and-immune Source: FDA website
Drug Recall 11-23-20
Benlysta
The Food and Drug Administration (FDA) approved Benlysta® (belimumab injection) for the treatment of adults with active lupus nephritis who are receiving standard therapy. Source: FDA website
New Indication 12-16-20
Xpovio
The Food and Drug Administration (FDA) approved Xpovio® (selinexor tablets) in combination with bortezomib and dexamethasone for the treatment of adults with multiple myeloma who have received at least one prior therapy. Source: FDA website
New Indication 12-18-20
Tagrisso
The Food and Drug Administration (FDA) approved Tagrisso® (osimertinib tablets) in adults with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by a Food and Drug Administration (FDA)-approved test. Source: FDA website
New Indication 12-18-20
Iclusig
The Food and Drug Administration (FDA) approved Iclusig® (ponatinib tablets) for adults with chronic-phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors. Source: FDA website
New Indication 12-18-20
Xeomin
The Food and Drug Administration (FDA) approved Xeomin® (incobotulinumtoxinA injection) for the treatment of individuals aged 2 years and older with chronic sialorrhea, or drooling. Source: FDA website
New Indication 12-18-20
Kineret
The Food and Drug Administration (FDA) approved Kineret® (anakinra injection) for treatment of deficiency of interleukin-1 receptor antagonist. Source: FDA website
New Indication 12-18-20
Arcalyst
The Food and Drug Administration (FDA) approved Arcalyst® (rilonacept injection) for maintenance of remission of deficiency of interleukin-1 receptor antagonist (DIRA) in adults and pediatric individuals weighing at least 10 kg. Source: FDA website
New Indication 12-18-20
Trikafta
The Food and Drug Administration (FDA) approved Trikafta® (elexacaftor/tezacaftor/ivacaftor and ivacaftor tablets) to include additional responsive mutations in people with cystic fibrosis ages 12 and older. Source: FDA website
Expanded Indication 12-21-20
Symdeko
The Food and Drug Administration (FDA) approved Symdeko® (tezacaftor/ivacaftor and ivacaftor) to include additional responsive mutations in people with cystic fibrosis ages 6 years and older. Source: FDA website
Expanded Indication 12-21-20
Kalydeco
The Food and Drug Administration (FDA) approved Kalydeco® (ivacaftor tablets and oral granules) to include additional responsive mutations in people with cystic fibrosis ages 4 months and older. Source: FDA website
Expanded Indication 12-21-20
Ebanga
The Food and Drug Administration (FDA) approved EbangaTM (ansuvimab-zykl injection) for the treatment of Zaire ebolavirus infection in adults and children. Source: FDA website
New Drug 12-21-20
Gemtesa
The Food and Drug Administration (FDA) approved Gemtesa® (vibegron tablets) for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. Source: FDA website
New Drug 12-23-20
Klisyri
The Food and Drug Administration (FDA) approved Klisyri® (tirbanibulin topical ointment) for the treatment of actinic keratosis of the face or scalp. Source: FDA website
New Drug 12-14-20
Margenza
The Food and Drug Administration (FDA) approved MargenzaTM (margetuximab-cmkb injection) in combination with chemotherapy, for the treatment of adults with metastatic human epidermal growth factor receptor 2 (HER2)- positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Source: FDA website
New Drug 12-16-20
Medical Action Industries
Medical Action Industries announced a voluntary recall of Medical Convenience Kits that include the BD/Carefusion Chloraprep 3 mL applicator due to risk of fungal contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/medical-devices/medical-device-recalls/medical-action-industries-inc-306-recalls-medical-convenience-kits-risk-fungal-aspergillus Source: FDA website
Drug Recall 05-24-21
Ocaliva
The Food and Drug Administration (FDA) is restricting the use of Ocaliva® (obeticholic acid tablets) in individuals with primary biliary cholangitis with advanced liver cirrhosis due to the potential for serious harm. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/ocaliva-obeticholic-acid-intercept-pharmaceuticals-drug-safety-communication-due-risk-serious-liver Source: FDA website
Drug Warning 05-26-21
Orgovyx
The Food and Drug Administration (FDA) approved OrgovyxTM (relugolix tablets) for the treatment of adults with advanced prostate cancer. Source: FDA website
New Drug 12-18-20
Sunstar Americas
Sunstar Americas expands an earlier voluntary recall of Paroex chlorhexidine gluconate oral rinse. 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-expands-voluntary-nationwide-recall-paroexr-chlorhexidine-gluconate-oral-rinse Source: FDA website
Drug Recall 12-29-20
Xalkori
The Food and Drug Administration (FDA) approved Xalkori® (crizotinib capsules) for pediatric individuals 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. Source: FDA website
Expanded Indication 01-14-21
Nostrum Laboratories
Nostrum Laboratories announced a voluntary recall of one lot of metformin extended release 750 mg tablets due to N-nitrosodimethylamine (NDMA) content 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/nostrum-laboratories-inc-expands-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets Source: FDA website
Drug Recall 01-05-21
Nostrum Laboratories
Nostrum Laboratories announced a voluntary recall of one additional lot of extended release metformin due to NDMA content above the acceptable limit. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin?utm_medium=email&utm_source=govdelivery Source: FDA website
Drug Recall 01-06-21
Paroex
Precision Dose announced a voluntary recall of all lots of Paroex® (chlorhexidine gluconate oral rinse) due to potential for microbial contamination. 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-paroex-chlorhexidine-gluconate-oral-rinse-usp Source: FDA website
Drug Recall 01-05-21
Curative SARS-CoV-2 Test
The Food and Drug Administration (FDA) is alerting healthcare providers and consumers of the risk of false results with the Curative SARS-CoV-2 test. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/medical-devices/safety-communications/risk-false-results-curative-sars-cov-2-test-covid-19-fda-safety-communication Source: FDA website
Drug Warning 01-07-21
Ketorolac tromethamine
Fresenius Kabi announced a voluntary recall of a single lot 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-ketorolac-tromethamine-injection-usp-due-presence Source: FDA website
Drug Recall 01-10-21
Enhertu
The Food and Drug Administration (FDA) approved Enhertu® (fam-trastuzumab deruxtecan-nxki injection) for adults with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Source: FDA website
New Indication 01-15-21
Darzalex Faspro
The Food and Drug Administration (FDA) approved Darzalex FasproTM (daratumumab/hyaluronidase-fihj injection) for use in combination with bortezomib, cyclophosphamide and dexamethasone (VCd), to treat adults with newly diagnosed light-chain (AL) amyloidosis. Source: FDA website
New Indication 01-15-21
Darzalex Faspro
The Food and Drug Administration (FDA) approved Darzalex FasproTM (daratumumab/hyaluronidase-fihj injection) for the treatment of multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed individuals who are eligible for autologous stem cell transplant. Source: FDA website
New Indication 01-11-21
Spritam
The Food and Drug Administration (FDA) approved Spritam® (levetiracetam tablets) for the treatment of partial-onset seizures in individuals 4 years of age and older weighing more than 20 kg. Source: FDA website
Expanded Indication 01-19-21
Verquvo
The Food and Drug Administration (FDA) approved Verquvo® (vericiguat tablets) to reduce the risk of cardiovascular death and heart failure (HF) hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%. Source: FDA website
New Drug 01-20-21
Cabenuva
The Food and Drug Administration (FDA) approved Cabenuva (cabotegravir/rilpivirine extended-release injection) for the treatment of human immunodeficiency virus (HIV)-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. Source: FDA website
New Drug 01-21-21
Vocabria
The Food and Drug Administration (FDA) approved Vocabria (cabotegravir tablets) in combination with rilpivirine for short-term treatment of human immunodeficiency virus (HIV)-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine, for use as: oral lead-in to assess the tolerability of cabotegravir prior to administration of Cabenuva (cabotegravir/rilpivirine extended-release injection) or oral therapy for individuals who will miss planned injection dosing with Cabenuva. Source: FDA website
New Drug 01-21-21
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) in combination with Cabometyx (cabozantinib tablets) as first-line treatment for individuals with advanced renal cell carcinoma. Source: FDA website
Expanded Indication 01-22-21
Edurant
The Food and Drug Administration (FDA) approved Edurant® (rilpivirine tablets) in combination with cabotegravir for short-term treatment of human immunodeficiency virus (HIV)-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine, for use as: oral lead-in to assess the tolerability of rilpivirine prior to administration of Cabenuva (cabotegravir/rilpivirine extended-release injection) or oral therapy for individuals who will miss planned injection dosing with Cabenuva. Source: FDA website
Expanded Indication 01-21-21
Carbaglu
The Food and Drug Administration (FDA) approved Carbaglu® (carglumic acid tablets for oral suspension) for adjunctive treatment of acute hyperammonemia due to propionic acidemia or methylmalonic acidemia. Source: FDA website
New Indication 01-22-21
Nplate
The Food and Drug Administration (FDA) approved Nplate® (romiplostim injection) to increase survival in adults and in pediatric individuals (including term neonates) acutely exposed to myelosuppressive doses of radiation. Source: FDA website
New Indication 01-28-21
Lupkynis
The Food and Drug Administration (FDA) approved LupkynisTM (voclosporin capsules) in combination with a background immunosuppressive therapy regimen for the treatment of adults with active lupus nephritis. Source: FDA website
New Drug 01-22-21
Nostrum Laboratories
Nostrum Laboratories announced a voluntary recall of one additional lot of extended release metformin due to N-nitrosodimethylamine (NDMA) content 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/nostrum-laboratories-inc-expands-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0 Source: FDA website
Drug Recall 01-26-21
Cisatracurium besylate
Meitheal Pharmaceuticals announced a voluntary recall of one lot of Cisatracurium besylate injection 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/meitheal-pharmaceuticals-inc-issues-voluntary-nationwide-recall-cisatracurium-besylate-injection-usp Source: FDA website
Drug Recall 01-28-21
Rapivab
The Food and Drug Administration (FDA) approved Rapivab® (peramivir injection) for the treatment of acute uncomplicated influenza in individuals 6 months and older who have been symptomatic for no more than two days. Source: FDA website
Expanded Indication 01-28-21
Gocovri
The Food and Drug Administration (FDA) approved Gocovri® (amantadine extended-release capsules) as an adjunctive treatment to levodopa/carbidopa in individuals with Parkinson’s disease experiencing OFF episodes. Source: FDA website
New Indication 02-01-21
Posimir
The Food and Drug Administration (FDA) approved Posimir® (bupivacaine solution for infiltration use) in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. Source: FDA website
New Formulation 02-01-21
Tepmetko
The Food and Drug Administration (FDA) approved Tepmetko® (tepotinib tablets) for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. Source: FDA website
New Drug 02-03-21
Enoxaparin sodium
Apotex announced a voluntary recall of two lots of enoxaparin sodium injection due to mislabeling of syringe barrel measurement markings. 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-enoxaparin-sodium-injection-usp-due-mislabeling Source: FDA website
Drug Recall 02-03-21
Xeljanz and Xeljanz XR
The Food and Drug Administration (FDA) is alerting consumers that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz® (tofacitinib tablets) and Xeljanz® XR (tofacitinib extended-release tablets) compared to another type of medicine called tumor necrosis factor (TNF) inhibitors. The FDA required the safety trial, which also investigated other potential risks including blood clots in the lungs and death. Those final results are not yet available. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/xeljanz-xeljanz-xr-tofacitinib-drug-safety-communication-initial-safety-trial-results-find-increased Source: FDA website
Drug Warning 02-04-21
Libtayo
The Food and Drug Administration (FDA) approved Libtayo® (cemiplimab-rwlc injection) for individuals with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. Source: FDA website
New Indication 02-09-21
Botox
The Food and Drug Administration (FDA) approved Botox® (onabotulinumtoxinA injection) for the treatment of detrusor (bladder muscle) overactivity associated with a neurologic condition in pediatric individuals 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication. Source: FDA website
New Indication 02-09-21
Panzyga
The Food and Drug Administration (FDA) approved Panzyga® (immune globulin injection) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). Source: FDA
New Indication 02-11-21
Ukoniq
The Food and Drug Administration (FDA) approved Ukoniq® (umbralisib tablets) for the treatment of adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. Source: FDA website
New Drug 02-05-21
Breyanzi
The Food and Drug Administration (FDA) approved Breyanzi® (lisocabtagene maraleucel suspension for intravenous infusion) for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. Source: FDA website
New Drug 02-05-21
Evkeeza
The Food and Drug Administration (FDA) approved EvkeezaTM (evinacumab-dgnb injection) as an add-on treatment for individuals aged 12 years and older with homozygous familial hypercholesterolemia (HoFH), a genetic condition that causes severely high cholesterol. Source: FDA website
New Drug 02-11-21
Cosela
The Food and Drug Administration (FDA) approved CoselaTM (trilaciclib injection) to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer. Source: FDA website
New Drug 02-12-21
Entresto
The Food and Drug Administration (FDA) approved Entresto® (sacubitril/valsartan tablets) in chronic heart failure to include individuals with heart failure with reduced ejection fraction (HFrEF), as well as many with heart failure with preserved ejection fraction (HFpEF). Source: FDA website
New Indication 02-16-21
Libtayo
The Food and Drug Administration (FDA) approved Libtayo® (cemiplimab-rwlc injection) for individuals with advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. Source: FDA website
New Indication 02-22-21
Humira
The Food and Drug Administration (FDA) approved Humira® (adalimumab injection) for the treatment of moderately to severely active ulcerative colitis in pediatric individuals 5 years of age and older. Source: FDA website
New Indication 02-24-21
Amondys 45
The Food and Drug Administration (FDA) approved Amondys 45 (casimersen 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 45 skipping. Source: FDA website
New Drug 02-25-21
Nulibry
The Food and Drug Administration (FDA) approved NulibryTM (fosdenopterin injection) to reduce the risk of mortality in individuals with molybdenum cofactor deficiency (MoCD) Type A. Source: FDA website
New Drug 02-26-21
Pepaxto
The Food and Drug Administration (FDA) approved Pepaxto® (melphalan flufenamide injection) in combination with dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. Source: FDA website
New Drug 02-26-21
Fabrazyme
The Food and Drug Administration (FDA) approved Fabrazyme® (agalsidase beta injection) for the treatment of adult and pediatric individuals 2 years of age and older with Fabry disease. Source: FDA website
New Indication 03-11-21
Arcalyst
The Food and Drug Administration (FDA) approved Arcalyst® (rilonacept injection) for the treatment of recurrent pericarditis and to reduce the risk of recurrence in individuals 12 years and older. Source: FDA website
New Indication 03-18-21
Kimyrsa
The Food and Drug Administration (FDA) approved Kimyrsa™ (oritavancin injection) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI). Source: FDA website
New Drug 03-15-21
Ponvory
The Food and Drug Administration (FDA) approved Ponvory™ (ponesimod tablets) for the treatment of adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Source: FDA website
New Drug 03-18-21
Phenylephrine
Sagent Pharmaceuticals announced a voluntary recall of three lots of phenylephrine hydrochloride injection due to potentially loose crimped vial overseals. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sagent-pharmaceuticals-inc-issues-voluntary-nationwide-recall-phenylephrine-hydrochloride-injection Source: FDA website
Drug Recall 03-12-21
Abecma
The Food and Drug Administration (FDA) approved Abecma® (idecabtagene vicleucel injection) for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Source: FDA website
New Drug 03-26-21
Acyclovir
Zydus Pharmaceuticals announced a voluntary recall of four lots of acyclovir sodium injection 50 mg/mL due to complaints of crystallization in vials. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/zydus-pharmaceuticals-usa-inc-issues-voluntary-nationwide-recall-acyclovir-sodium-injection-50-mgml Source: FDA website
Drug Recall 03-25-21
Benzedrex
The Food and Drug Administration (FDA) is warning that the abuse and misuse of the over-the-counter (OTC) nasal decongestant propylhexedrine can lead to serious harm such as heart and mental health problems. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/benzedrex-propylhexedrine-drug-safety-communication-fda-warns-abuse-and-misuse-nasal-decongestant Source: FDA website
Drug Warning 03-25-21
ChloraPrep
BD (Becton, Dickinson and Company) has expanded a voluntary recall that was initiated on June 23, 2020 for specified catalog numbers of the ChloraPrep™ 3 mL applicator due to possible fungal contamination under certain environmental conditions. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-expands-voluntary-recall-chlorapreptm-3-ml-applicator-nationwide-include-all-us-states Source: FDA website
Drug Recall 03-22-21
Exparel
The Food and Drug Administration (FDA) approved Exparel® (bupivacaine liposome injection) to include use in individuals 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia. Source: FDA website
Expanded Indication 03-22-21
Guanfacine
Apotex announced a voluntary recall of three lots of guanfacine extended-release tablets 2 mg due to trace amounts of quetiapine fumarate in one lot. 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-guanfacine-extended-release-tablets-2mg-due-trace Source: FDA website
Drug Recall 03-31-21
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) in combination with platinum and fluoropyrimidine-based chemotherapy for individuals with metastatic or locally advanced esophageal or gastroesophageal (GEJ) (tumors with epicenter 1 to 5 centimeters above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chemoradiation. Source: FDA website
New Indication 03-22-21
Lamictal
A Food and Drug Administration (FDA) review of a study showed a potential increased risk of heart rhythm problems in individuals with heart diease who are taking Lamictal (lamotrigine). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/lamictal-lamotrigine-drug-safety-communication-studies-show-increased-risk-heart-rhythm-problems Source: FDA website
Drug Warning 03-21-21
Myrbetriq
The Food and Drug Administration (FDA) approved Myrbetriq® (mirabegron extended-release tablets) for neurogenic detrusor overactivity (NDO) in pediatric individuals aged 3 years and older and weighing 35 kg or more. Source: FDA website
Expanded Indication 03-25-21
Myrbetriq
The Food and Drug Administration (FDA) approved Myrbetriq® (mirabegron extended-release oral suspension) for neurogenic detrusor overactivity (NDO) in pediatric individuals aged 3 years and older and weighing 35 kg or more. Source: FDA website
New Formulation 03-25-21
Praluent
The Food and Drug Administration (FDA) approved Praluent™ (alirocumab injection) for adults with homozygous familial hypercholesterolemia (HoFH). Praluent is not intended to be used alone but instead added to other treatments for HoFH. Source: FDA website
New Indication 04-01-21
Qelbree
The Food and Drug Administration (FDA) approved Qelbree™ (viloxazine extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in pediatric individuals 6 to 17 years of age. Source: FDA website
New Drug 04-02-21
Roszet
The Food and Drug Administration (FDA) approved Roszet® (rosuvastatin calcium/ezetimibe tablets) as an adjunct to diet in individuals with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDL-C) and alone or as an adjunct to other LDL-C lowering therapies in individuals with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C. Source: FDA website
New Formulation 03-23-21
Sarclisa
The Food and Drug Administration (FDA) approved Sarclisa® (isatuximab injection) in combination with carfilzomib and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy. Source: FDA website
New Indication 03-31-21
Telmisartan
Alembic Pharmaceuticals announced a voluntary recall of one lot of telmisartan tablets 20 mg due to a 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/alembic-pharmaceuticals-limited-issues-voluntary-nationwide-recall-telmisartan-tablets-usp-20-mg-due Source: FDA website
Drug Recall 03-25-21
Tyvaso
The Food and Drug Administration (FDA) approved Tyvaso® (treprostinil oral inhalation solution) for the treatment of individuals with pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. Source: FDA website
New Indication 03-31-21
Vyxeos
The Food and Drug Administration (FDA) approved Vyxeos® (daunorubicin/cytarabine injection) to treat newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in pediatric individuals aged one year and older. Source: FDA website
Expanded Indication 03-30-21
Zegalogue
The Food and Drug Administration (FDA) approved Zegalogue® (dasiglucagon injection) for the treatment of severe hypoglycemia in pediatric and adult individuals with diabetes aged 6 years and above. Source: FDA website
New Drug 03-22-21
Trodelvy
The Food and Drug Administration (FDA) approved Trodelvy® (sacituzumab govitecan-hziy injection) for use in adults with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. Source: FDA website
New Indication 04-13-21
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) in combination with certain types of chemotherapy, for the initial treatment of individuals with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma. Source: FDA website
New Indication 04-16-21
Ragwitek
The Food and Drug Administration (FDA) approved Ragwitek® (short ragweed pollen allergen extract tablet for sublingual use) to include individuals 5 to 17 years of age for the treatment of short ragweed pollen-induced allergic rhinitis. Source: FDA website
New Indication 04-19-21
Evekeo ODT
The Food and Drug Administration (FDA) approved Evekeo ODT® (amphetamine sulfate orally disintegrating tablets) to include individuals 3 to 5 years of age for the treatment of attention deficit hyperactivity disorder (ADHD). Source: FDA website
New Indication 04-16-21
Diovan
The Food and Drug Administration (FDA) approved Diovan® (valsartan tablets) to include individuals 1 to 5 years of age for the treatment of hypertension. Source: FDA website
New Indication 04-19-21
Natroba
The Food and Drug Administration (FDA) approved Natroba™ (spinosad topical suspension) for the treatment of scabies infestations in individuals 4 years of age and older. Source: FDA website
New Indication 04-28-21
Ferriprox
The Food and Drug Administration (FDA) approved Ferriprox® (deferiprone tablets and oral solution) for the treatment of transfusional iron overload due to sickle cell disease (SCD) or other anemias in adult and pediatric individuals 3 years of age and older. Source: FDA website
New Indication 04-30-21
Farxiga
The Food and Drug Administration (FDA) approved Farxiga® (dapagliflozin tablets) to include reducing the risk of kidney function decline, kidney failure, cardiovascular (CV) death and hospitalization for heart failure (HF) in adults with chronic kidney disease (CKD) who are at risk of disease progression. Source: FDA website
New Indication 04-30-21
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of individuals with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. Source: FDA website
New Indication 05-05-21
Kloxxado
The Food and Drug Administration (FDA) approved Kloxxado™ (naloxone hydrochloride nasal spray) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Source: FDA website
New Formulation 04-29-21
Nextstellis
The Food and Drug Administration (FDA) approved Nextstellis® (drospirenone/estetrol tablets) for use by females of reproductive potential to prevent pregnancy. Source: FDA website
New Drug 04-15-21
Jemperli
The Food and Drug Administration (FDA) approved Jemperli (dostarlimab-gxly injection) for the treatment of adults with mismatch repair deficient recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen. Source: FDA website
New Drug 04-22-21
Zynlonta
The Food and Drug Administration (FDA) approved Zynlonta™ (loncastuximab tesirine-lpyl injection) for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma. Source: FDA website
New Drug 04-23-21
NP Thyroid
Acella Pharmaceuticals announced a voluntary recall of certain lots of NP Thyroid® (15 mg, 30 mg, 60 mg, 90 mg, and 120 mg levothyroxine/liothyronine 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-certain-lots-np-thyroidr-thyroid-0 Source: FDA website
Drug Recall 05-01-21
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for individuals with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy. Source: FDA website
New Indication 05-20-21
Levothyroxine sodium
The Food and Drug Administration (FDA) approved Levothyroxine sodium 100 mcg/mL intravenous solution for the treatment of myxedema coma. Source: FDA website
New Formulation 05-17-21
Zynrelef
The Food and Drug Administration (FDA) approved ZynrelefTM (bupivacaine/meloxicam) extended-release solution for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty. Source: FDA website
New Drug 05-12-21
Empaveli
The Food and Drug Administration (FDA) approved EmpaveliTM (pegcetacoplan injection) for the treatment of adults with paroxysmal nocturnal hemoglobinuria. Source: FDA website
New Drug 05-14-21
Rybrevant
The Food and Drug Administration (FDA) approved RybrevantTM (amivantamab-vmjw injection) for the treatment of adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. Source: FDA website
New Drug 05-21-21
Novo Nordisk Insulins
Novo Nordisk announced a voluntary recall of 1,468 product samples of Levemir® (insulin detemir injection), Tresiba® (insulin degludec injection), Fiasp® (insulin aspart injection), Novolog® (insulin aspart injection), and Xultophy® (insulin degludec/liraglutide injection) because they were stored at temperatures below storage requirements. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novo-nordisk-issues-voluntary-nationwide-recall-levemirr-tresibar-fiaspr-novologr-and-xultophyr Source: FDA website
Drug Recall 05-10-21
Cosentyx
The Food and Drug Administration (FDA) approved Cosentyx® (secukinumab injection) to include treating moderate-to-severe plaque psoriasis in individuals as young as six years old who are candidates for systemic therapy or phototherapy. Source: FDA website
Expanded Indication 05-28-21
Ultomiris
The Food and Drug Administration (FDA) approved Ultomiris® (ravulizumab injection) to treat individuals aged one month and older with paroxysmal nocturnal hemoglobinuria (PNH). Source: FDA website
Expanded Indication 06-07-21
Lybalvi
The Food and Drug Administration (FDA) approved Lybalvi™ (olanzapine/samidorphan tablets) for the treatment of schizophrenia and bipolar 1 disorder in adults. Source: FDA website
New Drug 05-28-21
Wegovy
The Food and Drug Administration (FDA) approved Wegovy™ (semaglutide injection) as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adults. Source: FDA website
New Drug 06-04-21
Tembexa
The Food and Drug Administration (FDA) approved Tembexa® (brincidofovir tablets and oral suspension) for the treatment of human smallpox disease in adult and pediatric individuals, including neonates. Source: FDA website
New Drug 06-04-21
Truseltiq
The Food and Drug Administration (FDA) approved Truseltiq™ (infilgratinib capsules) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. Source: FDA website
New Drug 05-28-21
Ryplazim
The Food and Drug Administration (FDA) approved Ryplazim® (plasminogen injection) for the treatment of individuals with plasminogen deficiency type 1. Source: FDA website
New Drug 06-04-21
Brexafemme
The Food and Drug Administration (FDA) approved Brexafemme® (ibrexafungerp tablets) for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC). Source: FDA website
New Drug 06-01-21
Aduhelm
The Food and Drug Administration (FDA) approved Aduhelm™ (aducanumab-avwa injection) for the treatment of Alzheimer's disease. Source: FDA website
New Drug 06-07-21
Trikafta
The Food and Drug Administration (FDA) approved Trikafta® (elexacaftor/tezacaftor/ivacaftor tablets) to include children with cystic fibrosis (CF) ages 6 through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive to Trikafta based on in vitro data. Source: FDA website
Expanded Indication 06-08-21
Epclusa
The Food and Drug Administration (FDA) approved Epclusa® (sofosbuvir/velpatasvir tablets and oral pellets) for the treatment of chronic hepatitis C virus (HCV) in children as young as 3 years of age, regardless of HCV genotype or liver disease severity. Source: FDA website
Expanded Indication 06-10-21
Mavyret
The Food and Drug Administration (FDA) approved Mavyret® (glecaprevir/pibrentasvir tablet and oral pellets) for the treatment of chronic hepatitis C virus (HCV) in children as young as 3 years of age, regardless of HCV genotype or liver disease severity. Source: FDA website
Expanded Indication 06-10-21
Ayvakit
The Food and Drug Administration (FDA) approved Ayvakit® (avapritinib) for adults with advanced systemic mastocytosis (AdvSM), including those with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL). Source: FDA website
New Indication 06-16-21
Soaanz
The Food and Drug Administration (FDA) approved Soaanz® (torsemide tablets) in adults for the treatment of edema associated with heart failure or renal disease. Source: FDA website
New Formulation 06-14-21
Prevnar 20
The Food and Drug Administration (FDA) approved Prevnar 20™ (pneumococcal 20-valent conjugate vaccine) for the prevention of invasive disease and pneumonia caused by 20 Streptococcus pneumoniae (pneumococcus) serotypes in adults ages 18 years and older. Source: FDA website
New Formulation 06-08-21
Metformin
Viona Pharmaceuticals announced a voluntary recall of two lots of metformin hydrochloride extended-release 750 mg tablets due to the detection of nitrosodimethylamine (NDMA) impurities above acceptable daily limits. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viona-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets Source: FDA website
Drug Recall 06-13-21
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of individuals with locally advanced cutaneous squamous cell carcinoma (cSCC) that cannot be cured by surgery or radiation. Source: FDA website
New Indication 07-01-21
Padcev
The Food and Drug Administration (FDA) approved Padcev® (enfortumab vedotin-ejfv injection) for adults with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. Source: FDA website
New Indication 07-09-21
Solosec
The Food and Drug Administration (FDA) approved Solosec® (secnidazole oral granules) for the treatment of trichomoniasis in adults. Source: FDA website
New Indication 06-30-21
Toviaz
The Food and Drug Administration (FDA) approved Toviaz® (fesoterodine fumarate extended-release tablets) for the treatment of neurogenic detrusor overactivity (NDO) in pediatric individuals 6 years of age and older and weighing greater than 25 kg. Source: FDA website
New Indication 06-17-21
Pradaxa
The Food and Drug Administration (FDA) approved Pradaxa® (dabigatran etexilate oral pellets and capsules) to treat children 3 months to less than 12 years old with venous thromboembolism directly after they have been treated with a blood thinner given by injection for at least five days. The FDA also approved Pradaxa to prevent recurrent clots among individuals 3 months to less than 12 years old who completed treatment for their first venous thromboembolism. Source: FDA website
New Formulation/Expanded Indication 06-21-21
Verkazia
The Food and Drug Administration (FDA) approved Verkazia™ (cyclosporine ophthalmic emulsion) for the treatment of vernal keratoconjunctivitis (VKC) in children and adults. Source: FDA website
New Drug 06-23-21
Rylaze
The Food and Drug Administration (FDA) approved Rylaze™ (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in pediatric and adult individuals one month and older who have developed hypersensitivity to E. coli-derived asparaginase. Source: FDA website
New Drug 06-30-21
Kerendia
The Food and Drug Administration (FDA) approved Kerendia® (finerenone tablets) to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes. Source: FDA website
New Drug 07-09-21
DeRoyal Industries
DeRoyal Industries announced a voluntary recall of surgical procedure packs due to the packs containing 1% lidocaine that has been mislabeled as 0.5% bupivacaine. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/medical-devices/medical-device-recalls/deroyal-industries-recalls-surgical-procedure-packs-mislabeled-lidocaine Source: FDA website
Drug Recall 06-25-21
Topotecan
Teva Pharmaceuticals announced a voluntary recall of one lot of topotecan 4 mg/1 mL injection due to reports of particulates. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-initiates-voluntary-nationwide-recall-one-lot-topotecan-injection-4-mg4-ml-1-mgml-due-presence Source: FDA website
Drug Recall 07-01-21
Avid Medical
Avid Medical announced a voluntary recall of medical convenience kits that include the BD/Carefusion Chloraprep™ 3 mL applicator due to risk of fungal contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/medical-devices/medical-device-recalls/avid-medical-recalls-medical-convenience-kits-risk-fungal-contamination Source: FDA website
Drug Recall 06-25-21
Chantix
Pfizer announced a voluntary recall of nine lots of the smoking cessation drug Chantix® (varenicline tablets) due to potential levels of a nitrosamine impurity, called N-nitroso-varenicline, above the Food and Drug Administration (FDA) acceptable intake limit. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-and-patients-voluntary-recall-varenicline-chantix-warehouse Source: FDA website
Drug Recall 07-02-21
Darzalex Faspro
The Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab/hyaluronidase-fihj injection) in combination with pomalidomide and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. Source: FDA website
Expanded Indication 07-09-21
ArmonAir Digihaler
The Food and Drug Administration (FDA) approved ArmonAir® Digihaler® (fluticasone propionate oral inhaler) for the maintenance treatment of asthma as prophylactic therapy in pediatric individuals aged 4 to 11 years. Source: FDA website
Expanded Indication 07-09-21
Prograf
The Food and Drug Administration (FDA) approved Prograf® (tacrolimus injection, capsule, and oral suspension) for use in combination with other immunosuppressant drugs to prevent organ rejection in adult and pediatric individuals receiving lung transplantation. Source: FDA website
Expanded Indication 07-16-21
Vaxneuvance
The Food and Drug Administration (FDA) approved Vaxneuvance™ (pneumococcal 15-valent conjugate vaccine) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. Source: FDA website
New Formulation 07-16-21
Rezurock
The Food and Drug Administration (FDA) approved Rezurock™ (belumodsudil tablets) for the treatment of adult and pediatric individuals 12 years and older with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. Source: FDA website
New Drug 07-16-21
Fexinidazole
The Food and Drug Administration (FDA) approved Fexinidazole tablets for both stages of the Trypanosoma brucei gambiense form of sleeping sickness (Human African trypanosomiasis) in individuals 6 years of age and older and weighing at least 20 kg. Source: FDA website
New Drug 07-16-21
Innoveix Pharmaceuticals
Innoveix Pharmaceuticals announced a voluntary recall of all lots of sterile compounded 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/innoveix-pharmaceuticals-inc-issues-voluntary-recall-all-sterile-compounded-drug-products-due-lack-0 Source: FDA website
Drug Recall 07-14-21
Bydureon; Bydureon Bcise
The Food and Drug Administration (FDA) approved Bydureon™ (exenatide extended-release for injectable suspension) and Bydureon® BCise™ (exenatide extended-release injectable suspension) to be used in addition to diet and exercise to improve glycemic control in pediatric individuals 10 years or older with type 2 diabetes. Source: FDA website
Expanded Indication 07-22-21
Octagam 10%
The Food and Drug Administration (FDA) approved Octagam® 10% (immune globulin, human, injection) for the treatment of adult dermatomyositis. Source: FDA website
New Indication 07-20-21
Bylvay
The Food and Drug Administration (FDA) approved Bylvay™ (odevixibat oral capsules and pellets) for the treatment of pruritus (moderate to severe itching) in individuals with progressive familial intrahepatic cholestasis (PFIC) 3 months of age or older. Source: FDA website
New Drug 07-20-21
Chantix
Pfizer announced an expansion of a previous voluntary recall of Chantix™ (varenicline tablets) to 12 lots due to the presence of N-nitroso-varenicline 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/pfizer-issues-voluntary-nationwide-recall-twelve-lots-chantixr-varenicline-tablets-due-n-nitroso Source: FDA website
Drug Recall 07-19-21
Dalvance
The Food and Drug Administration (FDA) approved Dalvance® (dalbavancin injection) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric individuals from birth. Source: FDA website
Expanded Indication 07-22-21
Shingrix
The Food and Drug Administration (FDA) approved Shingrix (zoster vaccine recombinant adjuvanted suspension for intramuscular injection) in adults aged 18 years and older who are or will be at increased risk of herpes zoster due to immunodeficiency or immunosuppression caused by known disease or therapy. Source: FDA website
Expanded Indication 07-23-21
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of individuals with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery. Source: FDA website
Expanded Indication 07-26-21
Botox
The Food and Drug Administration (FDA) approved Botox® (onabotulinumtoxinA injection) to include 8 new muscles for the treatment of upper limb spasticity in adults, along with the use of ultrasound as a muscle localization technique in adult spasticity. Source: FDA website
Expanded Indication 07-28-21
Drizalma Sprinkle
The Food and Drug Administration (FDA) approved Drizalma SprinkleTM (duloxetine hydrochloride delayed release capsules) for the treatment of fibromyalgia in adults. Source: FDA website
New Indication 07-23-21
Nucala
The Food and Drug Administration (FDA) approved Nucala® (mepolizumab injection) as an add-on maintenance treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) in adults 18 years of age and older with inadequate response to nasal corticosteroids. Source: FDA website
New Indication 07-29-21
Twyneo
The Food and Drug Administration (FDA) approved Twyneo® (tretinoin/benzoyl peroxide topical cream) for the treatment of acne vulgaris in adults and pediatric individuals nine years of age and older. Source: FDA website
New Formulation 07-26-21
Pepaxto
The Food and Drug Administration (FDA) is alerting consumers and health care providers that a clinical trial evaluating Pepaxto® (melphalan flufenamide injection) with dexamethasone to treat individuals with multiple myeloma showed an increased risk of death. The FDA continues to evaluate this issue and will provide an update when new information is available. 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-about-clinical-trial-results-showing-increased
Drug Warning 07-28-21