Drug Information

View drug alerts Information in 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
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
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
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
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
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
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
Xywav
The Food and Drug Administration (FDA) approved Xywav® (calcium, magnesium, potassium, and sodium oxybates oral solution) for idiopathic hypersomnia (IH) in adults. Source: FDA website
New Indication 08-12-21
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the adjuvant treatment of individuals with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection. Source; FDA website
New Indication 08-19-21
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) in combination with lenvatinib for the first-line treatment of adults with advanced renal cell carcinoma (RCC). Source: FDA website
Expanded Indication 08-10-21
Mirena
The Food and Drug Administration (FDA) approved Mirena® (levonorgestrel-releasing intrauterine device) for the prevention of pregnancy for up to 7 years. Source: FDA website
Expanded Indication 08-11-21
Uptravi
The Food and Drug Administration (FDA) approved Uptravi® (selexipag injection for intravenous use) for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults with WHO functional class (FC) II–III, who are temporarily unable to take oral therapy. Source: FDA website
New Formulation 07-30-21
Ticovac
The Food and Drug Administration (FDA) approved Ticovac™ (tick-borne encephalitis vaccine injection) for active immunization to prevent tick-borne encephalitis (TBE) in individuals 1 year of age and older. Source: FDA website
New Vaccine 08-13-21
Saphnelo
The Food and Drug Administration (FDA) approved Saphnelo™ (anifrolumab-fnia injection) for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. Source: FDA website
New Drug 07-30-21
Nexviazyme
The Food and Drug Administration (FDA) approved Nexviazyme® (avalglucosidase alfa-ngpt injection) for the treatment of individuals 1 year of age and older with late-onset Pompe disease. Source: FDA website
New Drug 08-06-21
Welireg
The Food and Drug Administration (FDA) approved Welireg™ (belzutifan tablets) for treatment of adults with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. Source: FDA website
New Drug 08-13-21
Atovaquone
KVK Tech announced a voluntary recall of two lots of atovaquone oral suspension 750 mg/5 mL due to complaints of unusual grittiness. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kvk-tech-inc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp-750-mg5ml-due Source: FDA website
Drug Recall 08-10-21
Sodium bicarbonate
SterRx announced a voluntary recall of three lots of sodium bicarbonate 5% dextrose injection 150 mEq per 1,000 mL due to waterborne microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sterrx-llc-issues-voluntary-nationwide-recall-sodium-bicarbonate-5-dextrose-injection-150meq-1000-ml Source: FDA website
Drug Recall 08-11-21
Chantix
Pfizer announced a voluntary recall of an additional four lots of the smoking cessation agent Chantix® (varenicline tablets) due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level. Contact your healthcare provider with questions. More details may be viewed at:https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-expands-voluntary-nationwide-recall-include-four-additional-lots-chantixr-varenicline-tablets Source: FDA website
Drug Recall 08-17-21
Xarelto
The Food and Drug Administration (FDA) approved Xarelto® (rivaroxaban tablets) in combination with aspirin to reduce the risk of major thrombotic vascular events in individuals with peripheral artery disease (PAD), including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD. Source: FDA website
New Indication 08-23-21
Tibsovo
The Food and Drug Administration (FDA) approved TIbsovo® (ivosidenib tablets) for adults with previously treated, locally advanced or metastatic cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH1) mutation as detected by a Food and Drug Administered (FDA)-approved test. Source: FDA website
New Indication 08-25-21
Skytrofa
The Food and Drug Administration (FDA) approved Skytrofa® (lonapegsomatropin-tcgd injection) to treat pediatric individuals age one year and older who weigh at least 11.5 kg (25.4 pounds) and have short stature due to inadequate secretion of endogenous growth hormone. Source: FDA website
New Formulation 08-25-21
Korsuva
The Food and Drug Administration (FDA) approved Korsuva™ (difelikefalin injection) for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD). Source: FDA website
New Drug 08-23-21
Briviact
The Food and Drug Administration (FDA) approved Briviact® (brivaracetam tablets, oral solution, and injection) to include treatment of partial-onset seizures in individuals 1 month of age and older. Source: FDA website
Expanded Indication 08-27-21
Brukinsa
The Food and Drug Administration (FDA) approved Brukinsa® (zanubrutinib capsules) for adults with Waldenström's macroglobulinemia (WM). Source: FDA website
New Indication 08-31-21
Invega Hafyera
The Food and Drug Administration (FDA) approved Invega Hafyera™ (paliperidone palmitate injection) twice-yearly injectable for the treatment of schizophrenia in adults. Source: FDA website
New Formulation 08-30-21
Trudhesa
The Food and Drug Administration (FDA) approved Trudhesa™ (dihydroergotamine mesylate nasal inhalation) for the acute treatment of migraine with or without aura in adults. Source: FDA website
New Formulation 09-03-21
Lidocaine
Teligent announced a voluntary recall of one lot of lidocaine HCL topical solution 4% 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/teligent-pharma-incs-issues-voluntary-recall-lidocaine-hcl-topical-solution-4-lot-14218-exp-092022 Source: FDA website
Drug Recall 09-03-21
Janus kinase (JAK) inhibitors
The Food and Drug Administration (FDA) is requiring revisions to the Boxed Warning for Xeljanz®/Xeljanz XR® (tofacitinib tablets), Olumiant® (baricitinib tablets) and Rinvoq™ (upadacitinib tablets) to include information about the risks of serious heart-related events, cancer, blood clots, and death. Contact your healthcare provider with questions. More details may be viewed at :https://www.fda.gov/safety/medical-product-safety-information/janus-kinase-jak-inhibitors-drug-safety-communication-fda-requires-warnings-about-increased-risk?utm_medium=email&utm_source=govdelivery Source: FDA website
Drug Recall 09-03-21
Brukinsa
The Food and Drug Administration (FDA) approved Brukinsa® (zanubrutinib capsules) for the treatment of adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. Source: FDA website
New Indication 09-14-21
Exkivity
The Food and Drug Administration (FDA) approved Exkivity™ (mobocertinib capsules) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by a FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. Source: FDA website
New Drug 09-15-21
Aminosyn II 15%
ICU Medical announced a voluntary recall of one lot of Aminosyn® (amino acids injection) II 15% 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/icu-medical-issues-voluntary-nationwide-recall-aminosyn-ii-15-amino-acid-injection-sulfite-free-iv Source: FDA website
Drug Recall 09-09-21
Chantix
The Food and Drug Administration (FDA) announced a voluntary recall to include all lots of Chantix® (varenicline tablets) due to the presence of unacceptable N-nitroso-varenicline levels. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-expands-voluntary-nationwide-recall-include-all-lots-chantixr-varenicline-tablets-due-n Source: FDA website
Drug Recall 09-17-21
Firvanq
Azurity Pharmaceuticals announced a voluntary recall of one lot of Firvanq® (vancomycin hydrochloride for oral solution) due to a mix-up of the diluent included in the kit. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/azurity-pharmaceuticals-inc-issues-voluntary-nationwide-recall-one-lot-firvanqr-vancomycin
Drug Recall 09-09-21
Ruzurgi
Jacobus Pharmaceutical Company announced a voluntary recall of 3 lots of Ruzurgi® (amifampridine10 mg tablets) due to yeast, mold, and bacterial contamination based on laboratory test results. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/jacobus-pharmaceutical-company-inc-issues-voluntary-worldwide-recall-ruzurgir-amifampridine-10-mg Source: FDA website
Drug Recall 09-15-21
Greenpark Compounding Pharmacy
The Food and Drug Administration (FDA) alerted consumers and healthcare providers not to use compounded products intended to be sterile that were produced and distributed in the United States by Prescription Labs doing business as Greenpark Compounding Pharmacy due to lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at:https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-and-health-care-professionals-not-use-compounded-products-intended-be-sterile?utm_medium=email&utm_source=govdelivery Source: FDA website
Drug Warning 09-17-21
Cabometyx
The Food and Drug Administration (FDA) approved Cabometyx® (cabozantinib tablets) for the treatment of adult and pediatric individuals 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior vascular endothelial growth factor receptor (VEGFR)-targeted therapy and who are radioactive iodine-refractory or ineligible. Source: FDA website
New Indication 09-17-21
Jakafi
The Food and Drug Administration (FDA) approved Jakafi® (ruxolitinib tablets) for the treatment of chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy in adult and pediatric individuals 12 years and older. Source: FDA website
New Indication 09-22-21
Lexette
The Food and Drug Administration (FDA) approved Lexette™ (halobetasol propionate topical foam) to include individuals 12 years of age and older with plaque psoriasis. Source: FDA website
Expanded Indication 08-18-21
Opzelura
The Food and Drug Administration (FDA) approved Opzelura™ (ruxolitinib cream) for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised individuals 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Source: FDA website
New Formulation 09-21-21
Tivdak
The Food and Drug Administration (FDA) approved Tivdak™ (tisotumab vedotin-tftv for injection) for the treatment of adults with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Source: FDA website
New Drug 09-20-21
Cefazolin
IntegraDose Compounding Services announced a voluntary recall of nine lots of cefazolin 2 gram in 20 mL syringe for injection and two lots of cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/integradose-compounding-services-llc-issues-voluntary-nationwide-recall-cefazolin-injection-products?utm_medium=email&utm_source=govdelivery Source: FDA website
Drug Recall 09-22-21
Repatha
The Food and Drug Administration (FDA) approved Repatha® (evolocumab injection) as an add-on treatment to diet alone or together with certain other therapies for individuals aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH). Source: FDA website
New Indication 09-24-21
Erbitux
The Food and Drug Administration (FDA) approved Erbitux® (cetuximab injection) in combination with Braftovi® (encorafenib capsules) for the treatment of adults with metastatic colorectal cancer with a BRAF V600E mutation, as detected by a Food and Drug Administration (FDA)-approved test, after prior therapy. Source: FDA website
New Indication 09-24-21
Qulipta
The Food and Drug Administration (FDA) approved Qulipta™ (atogepant tablets) for the preventive treatment of episodic migraine in adults. Source: FDA website
New Drug 09-28-21
Livmarli
The Food and Drug Administration (FDA) approved Livmarli™ (maralixibat oral solution) for the treatment of cholestatic pruritus in individuals with Alagille syndrome one year of age and older. Source: FDA website
New Drug 09-29-21
Glucagon
Eli Lilly and Company announced a voluntary recall of one lot of Glucagon™ (glucagon for injection) Emergency Kit due to a report that the vial was in liquid form instead of the powder form. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eli-lilly-and-company-issues-voluntary-nationwide-recall-one-lot-glucagonr-emergency-kit-due-loss Source: FDA website
Drug Recall 09-27-21
Tecartus
The Food and Drug Administration (FDA) approved Tecartus® (brexucabtagene autoleucel injection) for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Source: FDA website
New Indication 10-01-21
Zercapli
The Food and Drug Administration (FDA) approved Zercapli (sertraline hydrochloride capsules) for the treatment of major depressive disorder in adults and for the treatment of obsessive-compulsive disorder in adults and pediatric individuals 6 years and older. Source: FDA website
New Indication 10-04-21
Tavneos
The Food and Drug Administration (FDA) approved Tavneos™ (avacopan capsules) as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (also known as ANCA-associated vasculitis or ANCA vasculitis), specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) (the two main forms of ANCA vasculitis), in combination with standard therapy. Source: FDA website
New Drug 10-08-21
Dextenza
The Food and Drug Administration (FDA) approved Dextenza® (dexamethasone intraocular suspension) for the treatment of ocular itching associated with allergic conjunctivitis. Source: FDA website
New Indication 10-11-21
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) ) in combination with chemotherapy, with or without bevacizumab, for individuals with persistent, recurrent or metastatic cervical cancer whose tumors express programmed death ligand-1 (PD-L1) combined positive score (CPS) ≥1, as determined by a Food and Drug Administration (FDA)-approved test. Source: FDA website
New Indication 10-13-21
Verzenio
The Food and Drug Administration (FDA) approved Verzenio® (abemaciclib tablets) approved in combination with endocrine therapy for the adjuvant treatment of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence and a Ki-67 score of ≥20% as determined by a Food and Drug Administration (FDA)-approved test. Source: FDA website
Expanded Indication 10-12-21
Tecentriq
The Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab injection) for adjuvant treatment following resection and platinum-based chemotherapy in individuals with stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have programmed death ligand-1 (PD-L1) expression on ≥ 1% of tumor cells, as determined by a Food and Drug Administration (FDA)-approved test. Source: FDA website
Expanded Indication 10-15-21
Biktarvy
The Food and Drug Administration (FDA) approved Biktarvy® (bictegravir/ emtricitabine/tenofovir alafenamide tablets) to include treatment of human immunodeficiency virus (HIV)-1 infected pediatric individuals weighing at least 14 kg. Source: FDA website
Expanded Indication 10-07-21
Rethymic
The Food and Drug Administration (FDA) approved Rethymic® (allogeneic processed thymus tissue-agdc surgical implant) for immune reconstitution in children with congenital athymia. Source: FDA website
New Drug 10-08-21
Lidocaine 4%
Teligent Pharma announced a voluntary recall of 5 lots of Lidocaine 4% topical solution 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/teligent-pharma-incs-issues-worldwide-voluntary-recall-lidocaine-hcl-topical-solution-4-due-super Source: FDA website
Drug Recall 10-13-21
Irbesartan; Irbesartan/Hydrochlorothiazide
Lupin Pharmaceuticals announced a voluntary recall of all batches of irbesartan tablets and irbesartan/hydrochlorothiazide tablets due to the potential presence of N-nitrosoirbesartan impurity. 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-all-irbesartan-tablets-and-irbesartan Source: FDA website
Drug Recall 10-14-21
Flucelvax Quadrivalent
The Food and Drug Administration (FDA) approved Flucelvax® Quadrivalent (influenza vaccine injection) for active immunization in individuals 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. Source: FDA website
Expanded Indication 10-15-21
Vimpat
The Food and Drug Administration (FDA) approved Vimpat® (lacosamide tablet, oral solution, and injection) for monotherapy and adjunctive therapy in the treatment of partial onset seizures in individuals 1 month and older to less than 4 years of age. Source: FDA website
Expanded Indication 10-14-21
Zimhi
The Food and Drug Administration (FDA) approved ZimhiTM (naloxone injection) for use in the treatment of opioid overdose. Source: FDA website
New Formulation 10-15-21
Seglentis
The Food and Drug Administration (FDA) approved Seglentis (celecoxib/tramadol tablets) for the treatment of acute pain in adults. Source: FDA website
New Formulation 10-18-21
Tyrvaya
The Food and Drug Administration (FDA) approved TyrvayaTM (varenicline nasal spray) for the treatment of the signs and symptoms of dry eye disease. Source: FDA website
New Drug 10-15-21
Methocarbamol
Bryant Ranch Prepack announced a voluntary recall of one lot of methocarbamol 500 mg 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-methocarbamol-500mg-bottles-due-mislabeling Source: FDA website
Drug Recall 10-19-21
Dupixent
The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) for add-on maintenance treatment in moderate-to-severe asthma in children ages 6 to 11 years. Source: FDA website
Expanded Indication 10-20-21
Cutaquig
The Food and Drug Administration (FDA) approved Cutaquig® (human immune globulin subcutaneous injection) in pediatric individuals 2 years of age and older for the treatment of primary humoral immunodeficiency. Source: FDA website
Expanded Indication 10-22-21
Susvimo
The Food and Drug Administration (FDA) approved SusvimoTM (ranibizumab injection) for intravitreal use via ocular implant for the treatment of people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections. Source: FDA website
New Formulation 10-22-21
Xipere
The Food and Drug Administration (FDA) approved XipereTM (triamcinolone acetonide injection for suprachoroidal use) for the treatment of macular edema associated with uveitis. Source: FDA website
New Formulation 10-22-21
Vuity
The Food and Drug Administration (FDA) approved VuityTM (pilocarpine 1.25% ophthalmic solution) for the treatment of presbyopia in adults. Source: FDA website
New Formulation 10-28-21
Purified Cortrophin Gel
The Food and Drug Administration (FDA) approved Purified Cortrophin® Gel (repository corticotropin injection) for the treatment of rheumatic disorders, collagen diseases, dermatologic diseases, allergic states, ophthalmic disease, respiratory diseases, edematous states, and acute exacerbation of multiple sclerosis. Source: FDA website
New Formulation 11-01-21
Scemblix
The Food and Drug Administration (FDA) approved Scemblix® (asciminib tablets) for the treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs) and for the treatment of adults with Ph+ CML in CP with T315I mutation. Source: FDA website
New Drug 10-29-21
Monoject Flush Prefilled Saline Syringes
Aligned Medical Solutions announced a voluntary recall of Cardinal Health's MonojectTM Flush Prefilled Saline Syringes placed into kits due to the potential for the plunger to draw back after air has been expelled allowing for reintroduction of air back into the syringe. Contact your healthcare provider with questions. Details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/windstone-medical-packaging-dba-aligned-medical-solutions-issues-nationwide-recall-cardinal-healths Source: FDA website
Drug Recall 10-28-21
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the adjuvant treatment of individuals with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. Source: FDA website
New Indication 11-17-21
Dyanavel XR
The Food and Drug Administration (FDA) approved Dyanavel® XR (amphetamine extended-release tablets) for the treatment of attention deficit hyperactivity disorder (ADHD) in individuals 6 years of age and older. Source: FDA website
New Formulation 11-04-21
Eprontia
The Food and Drug Administration (FDA) approved EprontiaTM (topiramate oral solution) as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in individuals 2 years of age or older: adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in individuals 2 years of age and older; and preventive treatment of migraine in individuals12 years of age and older. Source: FDA website
New Formulation 11-05-21
Dhivy
The Food and Drug Administration (FDA) approved DhivyTM (carbidopa/levodopa tablets) for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Source: FDA website
New Formulation 11-12-21
Besremi
The Food and Drug Administration (FDA) approved Besremi® (ropeginterferon alfa-2b-njft injection) for the treatment of adults with polycythemia vera (PV). Source: FDA source
New Drug 11-12-21
Voxzogo
The Food and Drug Administration (FDA) approved VoxzogoTM (vosoritide injection) to increase linear growth in pediatric individuals with achondroplasia who are 5 years of age and older with open epiphyses. Source: FDA website
New Drug 11-19-21
SterRx
SterRx announced a voluntary recall of approximately 240 lots of products due to lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sterrx-llc-issues-voluntary-nationwide-recall-certain-sterrx-products Source: FDA website
Drug Recall 11-16-21
Injectafer
The Food and Drug Administration (FDA) approved Injectafer® (ferric carboxymaltose injection) for pediatric individuals 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron. Source: FDA website
Expanded Indication 11-19-21
Darzalex Faspro
The Food and Drug Administration (FDA) approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj injection) in combination with carfilzomib plus dexamethasone for adults with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. Source: FDA website
Expanded Indication 11-30-21
Lyvispah
The Food and Drug Administration (FDA) approved Lyvispah (baclofen oral granules) for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Lyvispah may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Source: FDA website
New Formulation 11-22-21
Livtencity
The Food and Drug Administration (FDA) approved Livtencity (maribavir tablets) for the treatment of adults and pediatric individuals (≥12 years of age and weighing ≥35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet. Source: FDA website
New Drug 11-23-21
Fyarro
The Food and Drug Administration (FDA) approved Fyarro™ (sirolimus protein-bound particles for injectable suspension) for the treatment of adults with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa), Source: FDA website
New Drug 11-22-21
PreHevbrio
The Food and Drug Administration (FDA) approved PreHevbrio™ (recombinant hepatitis B vaccine injection) for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults age 18 years and older. Source: FDA website
New Vaccine 12-01-21
Rituxan
The Food and Drug Administration (FDA) approved Rituxan® (rituximab injection) approved in combination with chemotherapy for pediatric individuals (≥6 months to <18 years) with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL). Source: FDA website
New Indication 12-02-21
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the adjuvant treatment of adult and pediatric (12 years and older) individuals with stage IIB or IIC melanoma following complete resection. Additionally, the Food and Drug Administration (FDA) expanded the indication for Keytruda as adjuvant treatment for stage III melanoma following complete resection to include pediatric individuals (12 years and older). Source: FDA website
New Indication 12-03-21
Siklos
The Food and Drug Administration (FDA) approved Siklos® (hydroxyurea tablets) to include adults to reduce the frequency of painful crises and to reduce the need for blood transfusions in adult and pediatric individuals, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crises. Source: FDA website
New Indication 12-07-21
Zynrelef
The Food and Drug Administration (FDA) approved Zynrelef® (bupivacaine/meloxicam extended-release solution for soft tissue or periarticular instillation) in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. Source: FDA website
Expanded Indication 12-08-21
Xaciato
The Food and Drug Administration (FDA) approved XaciatoTM (clindamycin phosphate vaginal gel) for the treatment of bacterial vaginosis in females 12 years of age and older. Source: FDA website
New Formulation 12-07-21
Enoxaparin sodium
Sandoz announced a voluntary recall of one lot of enoxaparin sodium injection due to temperature excursion during shipment. Contact your healthcare provider for questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-nationwide-recall-one-lot-enoxaparin-sodium-injection-usp-40mg04-ml-due Source: FDA website
Drug Recall 12-03-21
Zepatier
The Food and Drug Administration (FDA) approved ZepatierTM (elbasvir/grazoprevir tablets) for the treatment of individuals aged 12 to less than 18 years with chronic hepatitis C (HCV) genotype 1 or 4 infection without cirrhosis. Source: FDA website
Expanded Indication 12-09-21
Oxbryta
The Food and Drug Administration (FDA) approved Oxbryta® (voxelotor tablets and tablets for oral suspension) to treat sickle cell disease in pediatric individuals aged four up to 11 years. Source: FDA website
Expanded Indication/New Dosage Form 12-17-21
Rinvoq
The Food and Drug Administration (FDA) approved Rinvoq® (upadacitinib extended-release tablets) for the treatment of adults with active psoriatic arthritis who have had an inadequate response, or intolerance to, tumor necrosis factor (TNF) inhibitors. Source: FDA website
New Indication 12-14-21
Xeljanz/Xeljanz XR
The Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib tablets) and Xeljanz® XR (tofacitinib extended-release tablets) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. Source: FDA website
New Indication 12-14-21
Orencia
The Food and Drug Administration (FDA) approved Orencia® (abatacept injection) for the prophylaxis of acute graft-versus-host disease (aGVHD) in combination with certain immunosuppressants. Source: FDA website
New Indication 12-15-21
Entadfi
The Food and Drug Administration (FDA) approved EntadfiTM (finasteride/tadalafil capsules) for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks. Source: FDA website
New Formulation 12-09-21
Tarpeyo
The Food and Drug Administration (FDA) approved TarpeyoTM (budesonide delayed-release capsules) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. Source: FDA website
New Formulation 12-15-21
Clozapine
The Food and Drug Administration (FDA) authorizes enforcement discretion to temporarily ease certain requirements of the clozapine risk evaluation and mitigation strategy (REMS) to help ensure continuity of care. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-temporarily-exercising-enforcement-discretion-respect-certain-clozapine-rems-program?utm_medium=email&utm_source=govdelivery Source: FDA website
Drug Warning 12-16-21
Xarelto
The Food and Drug Administration (FDA) approved Xarelto® (rivaroxaban tablets and oral suspension) to treat venous thromboembolism (VTE) and to reduce the risk of VTE recurring in pediatric individuals from birth to younger than 18 years who have received at least five days of injectable or intravenous treatment for blood clots. It was also approved to prevent blood clots in pediatric individuals two years and older with congenital heart disease after the Fontan procedure, a type of open-heart surgery. Source: FDA website
Expanded Indication/New Dosage Form 12-20-21
Otezla
The Food and Drug Administration (FDA) approved Otezla® (apremilast tablets) for the treatment of adults with plaque psoriasis who are candidates for phototherapy or systemic therapy, regardless of severity level. Source: FDA website
Expanded Indication 12-20-21
Caplyta
The Food and Drug Administration (FDA) approved Caplyta® (lumateperone capsules) for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate. Source: FDA website
New Indication 12-17-21
Vocabria
The Food and Drug Administration (FDA) approved Vocabria (cabotegravir sodium tablets) as oral lead-in to assess the tolerability of cabotegravir prior to administration of cabotegravir extended-release injectable suspension for human immunodeficiency (HIV)-1 pre-exposure prophylaxis (PrEP) and oral therapy for individuals who will miss planned injection dosing with cabotegravir injectable for HIV-1 PrEP.Source: FDA website
New Indication 12-20-21
Cosentyx
The Food and Drug Administration (FDA) approved Cosentyx® (secukinumab injection) for the treatment of active enthesitis-related arthritis (ERA) in individuals four years and older and active psoriatic arthritis (PsA) in individuals two years and older. Source: FDA website
New Indication 12-22-21
Dartisla ODT
The Food and Drug Administration (FDA) approved Dartisla ODT (glycopyrrolate orally disintegrating tablets) in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Source: FDA website
New Formulation 12-16-21
Apretude
The Food and Drug Administration (FDA) approved Apretude (cabotegravir extended-release injectable suspension) in at-risk adults and adolescents weighing at least 35 kg for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP). Source: FDA website
New Formulation 12-20-21
Leqvio
The Food and Drug Administration (FDA) approved Leqvio® (inclisiran injection) as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Source: FDA website
New Drug 12-22-21
Vyvgart
The Food and Drug Administration (FDA) approved VyvgartTM (efgartigimod alfa-fcab injection) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody positive. Source: FDA website
New Drug 12-17-21
Tezspire
The Food and Drug Administration (FDA) approved TezspireTM (tezepelumab-ekko injection) as add-on maintenance treatment of adult and pediatric individuals aged 12 years and older with severe asthma. Source: FDA website
New Drug 12-17-21
Rexulti
The Food and Drug Administration (FDA) approved Rexulti® (brexpiprazole tablets) for the treatment of schizophrenia in individuals aged 13 to 17 years. Source: FDA website
Expanded Indication 12/27/2021
Tascenso ODT
The Food and Drug Administration (FDA) approved Tascenso ODTTM (fingolimod lauryl sulfate orally disintegrating tablets) for the treatment of relapsing forms of multiple sclerosis (MS) to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in pediatric individuals 10 years of age and older and weighing less than or equal to 40 kg. Source: FDA website
New Formulation 12/23/2021
Adbry
The Food and Drug Administration (FDA) approved AdbryTM (tralokinumab-ldrm injection) for moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Source: FDA website
New Drug 12/27/2021
Recorlev
The Food and Drug Administration (FDA) approved Recorlev® (levoketoconazole tablets) for the treatment of adults with Cushing’s syndrome with endogenous high cortisol levels for whom surgery is not an option or has not been curative. Source: FDA website
New Drug 12/30/2021
Metformin
Viona announced a voluntary recall of thirty three lots of metformin hydrochloride extended-release tablets 750 mg due to the detection of N-nitrosodimethylamine (NDMA) impurity. 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-0 Source: FDA website
Drug Recall 12/29/2021
Clobetasol propionate ointment
Taro Pharmaceuticals announced a voluntary recall of one lot of clobetasol propionate ointment 0.05% packaged in 60 gram tubes 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/taro-pharmaceuticals-usa-issues-voluntary-nationwide-recall-clobetasol-propionate-ointment-usp-005 Source: FDA website
Drug Recall 12/31/2021
Nitroglycerin lingual spray
Padagis announces a voluntary recall of nitroglycerin lingual spray due to a possible defective delivery system. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/padagis-issues-voluntary-nationwide-recall-nitroglycerin-lingual-spray-due-possible-defective Source: FDA website
Drug Recall 12/27/2021
Descovy
The Food and Drug Administration (FDA) approved Descovy® (emtricitabine/tenofovir alafenamide fumarate tablets) to include treatment of human immunodeficiency virus (HIV)-1 infection in pediatric individuals at least 2 years of age and weighing at least 14 kg.Source: FDA website
Expanded Indication 01-07-22
Quviviq
The Food and Drug Administration (FDA) approved Quviviq (daridorexant tablets) for the treatment of adults with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.Source: FDA website
New Drug 01-07-22
Senna
Lohxa announced a voluntary recall of one lot of Senna Syrup 8.8 mg/5 mL unit-dose cups 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-senna-syrup-88mg5ml-due-microbial-contamination Source: FDA website
Drug Recall 01-13-22
Metformin
Viona Pharmaceuticals announced a voluntary recall of twenty-three lots of metformin hydrochloride extended-release tablets 750 mg due to detection of N-nitrosamine (NDMA) impurity. 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-0 Source: FDA website
Drug Recall 01-12-22
Buprenorphine
The Food and Drug Administration (FDA) is warning that dental problems (tooth decay, cavities, oral infection, and loss of teeth) have been reported with medicines containing buprenorphine that are dissolved in the mouth for opioid use disorder and pain. The FDA is requiring a new warning be added to the prescribing information. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/buprenorphine-drug-safety-communication-fda-warns-about-dental-problems-buprenorphine-medicines Source: FDA website
Drug Warning 01-12-22
Rinvoq
The Food and Drug Administration (FDA) approved Rinvoq® (upadacitinib tablets) for the treatment of adults and children 12 years of age and older with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Source: FDA website
New Indication 01-14-22
Skyrizi
The Food and Drug Administration (FDA) approved SkyriziTM (risankizumab-rzaa injection) for the treatment of adults with active psoriatic arthritis (PsA). Source: FDA website
New Indication 01-24-22
Veklury
The Food and Drug Administration (FDA) approved Veklury® (remdesivir injection) for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric individuals (12 years of age and older and weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. Source: FDA website
Expanded Indication 01-21-22
Ryaltris
The Food and Drug Administration (FDA) approved RyaltrisTM (olopatadine hydrochloride/mometasone furoate nasal spray) for the treatment of symptoms of seasonal allergic rhinitis in adults and pediatric individuals 12 years of age and older. Source: FDA website
New Formulation 01-13-22
Cibinqo
The Food and Drug Administration (FDA) approved CibinqoTM (abrocitinib tablets) for the treatment of adults with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Source: FDA website
New Drug 01-14-22
Semglee
Mylan Pharmaceuticals announced a voluntary recall of one batch of its non-interchangeable Semglee injection due to the potential for a missing label. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-conducting-voluntary-recall-one-batch-semgleer-insulin Source: FDA website
Drug Recall 01-19-22
Solosec
The Food and Drug Administration (FDA) approved Solosec® (secnidazole oral granules) for the treatment of bacterial vaginosis and trichomoniasis caused by Trichomonas vaginalis in individuals 12 years of age and older. Source: FDA website
Expanded Indication 01-26-22
Pifeltro
The Food and Drug Administration (FDA) approved Pifeltro® (doravirine tablets) for the treatment of human immunodeficiency virus (HIV)-1 in pediatric individuals weighing at least 35 kg. Source: FDA website
Expanded Indication 01-27-22
Delstrigo
The Food and Drug Administration (FDA) approved DelstrigoTM (doravirine/lamivudine/tenofovir disoproxil fumarate tablets) for the treatment of human immunodeficiency virus (HIV)-1 in pediatric individuals weighing at least 35 kg. Source: FDA website
Expanded Indication 01-27-22
Vonvendi
The Food and Drug Administration (FDA) approved Vonvendi® (recombinant von Willebrand factor injection) for routine prophylaxis to reduce the frequency of bleeding episodes in individuals with severe Type 3 von Willebrand disease (VWD) receiving on-demand therapy. Source: FDA website
Expanded Indication 01-31-22
Nucala
The Food and Drug Administration (FDA) approved Nucala (mepolizumab 40 mg prefilled syringe injection) as add-on maintenance treatment for children 6 to 11 years of age with severe asthma and with an eosinophilic phenotype. Source: FDA website
New Formulation 01-22-22
Kimmtrak
The Food and Drug Administration (FDA) approved Kimmtrak® (tebentafusp-tebn injection) for the treatment of human leukocyte antigen (HLA)-A*02:01-positive adults with unresectable or metastatic uveal melanoma (mUM). Source: FDA website
New Drug 01-26-22
Vabysmo
The Food and Drug Administration (FDA) approved VabysmoTM (faricimab-svoa injection for intravitreal use) for the treatment of adults with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME). Source: FDA website
New Drug 01-28-22
Polymyxin B
AuroMedics Pharma announced a voluntary recall of one lot of polymyxin B for injection due to a product complaint for 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/auromedics-pharma-llc-issues-voluntary-nationwide-recall-polymyxin-b-injection-usp-500000-unit-vial Source: FDA website
Drug Recall 01-28-22
Xigduo XR
The Food and Drug Administration (FDA) approved Xigduo® XR (dapagliflozin/metformin hydrochloride extended-release tablets) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction. Source: FDA website
New Indication 02-03-22
Fleqsuvy
The Food and Drug Administration (FDA) approved FleqsuvyTM (baclofen oral suspension) for the treatment of spasticity resulting from multiple sclerosis (MS), particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Source: FDA website
New Formulation 02-04-22
Enjaymo
The Food and Drug Administration (FDA) approved EnjaymoTM (sutimlimab-jome injection) to decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD). Source: FDA website
New Drug 02-04-22
Ukoniq
The Food and Drug Administration (FDA) is investigating a possible increased risk of death due to the cancer drug Ukoniq® (umbralisib tablets). The FDA is re-evaluating the risk versus benefit of Ukoniq and is continuing to look at results from the UNITY clinical trial. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/ukoniq-umbralisib-drug-safety-communication-fda-investigating-possible-increased-risk-death-lymphoma Source: FDA website
Drug Warning 02-03-22
Jardiance
The Food and Drug Administration (FDA) approved Jardiance® (empagliflozin tablets) to treat adults with heart failure regardless of left ventricular ejection fraction. Source: FDA website
Expanded Indication 02-24-22
Norliqva
The Food and Drug Administration (FDA) approved Norliqva® (amlodipine oral solution) for the treatment of hypertension in adults and children 6 years and older and for the treatment of coronary artery disease and angiographically documented coronary artery disease in individuals without heart failure or an ejection fraction <40%. Source: FDA website
New Formulation 02-24-22
Aspruzyo Sprinkle
The Food and Drug Administration (FDA) approved Aspruzyo SprinkleTM (ranolazine extended-release oral granules) for the treatment of chronic angina. Source: FDA website
New Formulation 02-28-22
Pyrukynd
The Food and Drug Administration (FDA) approved Pyrukynd® (mitapivat tablets) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency. Source: FDA website
New Drug 02-17-22
Carvykti
The Food and Drug Administration (FDA) approved CarvyktiTM (ciltacabtagene autoleucel suspension for intravenous infusion) for the treatment of adults with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Source: FDA website
New Drug 02-28-22
Vonjo
The Food and Drug Administration (FDA) approved VonjoTM (pacritinib capsules) for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. Source: FDA website
New Drug 02-28-22
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) in combination with platinum-doublet chemotherapy for adults with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting. Source: FDA website
Expanded Indication 03-04-22
Lynparza
The Food and Drug Administration (FDA) approved Lynparza® (olaparib tablets) for the adjuvant treatment of adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Source: FDA website
Expanded Indication 03-11-22
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) as a single agent for individuals with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by a Food and Drug Administration (FDA)-approved test, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation. Source: FDA website
Expanded Indication 03-21-22
Smoflipid
The Food and Drug Administration (FDA) approved Smoflipid® (lipid injectable emulsion) as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated expanded to include pediatric individuals. Source: FDA website
Expanded Indication 03-22-22
Rinvoq
The Food and Drug Administration (FDA) approved Rinvoq® (upadacitinib extended-release tablets) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. Source: FDA website
New Indication 03-16-22
Adlarity
The Food and Drug Administration (FDA) approved Adlarity® (donepezil transdermal system) for the treatment of adults with mild, moderate, and severe dementia of the Alzheimer type. Source: FDA website
New Formulation 03-11-22
Xelstrym
The Food and Drug Administration (FDA) approved XelstrymTM (dextroamphetamine transdermal system) for the treatment of attention-deficit/hyperactivity disorder (ADHD) for adults and pediatric individuals 6 years and older. Source: FDA website
New Formulation 03-23-22
Hyftor
The Food and Drug Administration (FDA) approved HyftorTM (sirolimus topical gel) for the treatment of facial angiofibroma associated with tuberous sclerosis in adults and pediatric individuals 6 years of age and older. Source: FDA website
New Formulation 03-22-22
Ztalmy
The Food and Drug Administration (FDA) approved Ztalmy® (ganaxolone oral suspension) for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in individuals 2 years of age or older. Source: FDA website
New Drug 03-18-22
Opdualag
The Food and Drug Administration (FDA) approved OpdualagTM (nivolumab/relatlimab-rmbw injection) for the treatment of adult and pediatric individuals 12 years of age or older with unresectable or metastatic melanoma. Source: FDA website
New Drug 03-18-2022
Pluvicto
The Food and Drug Administration (FDA) approved PluvictoTM (lutetium Lu 177 vipivotide tetraxetan injection) for the treatment of adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. Source: FDA website
New Drug 03-23-22
Sodium acetate
Fresenius Kabi announced a voluntary recall of seven lots of sodium acetate 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-recall-sodium-acetate-injection-usp-due-presence-particulate-matter Source: FDA website
Drug Recall 03-08-22
Quinapril/hydrochlorothiazide
Pfizer announced a voluntary recall of six lots of AccureticTM (quinapril HCL/hydrochlorothiazide) tablets distributed by Pfizer as well as five lots of two authorized generics distributed by Greenstone due to the presence of an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-voluntary-nationwide-recall-lots-accuretictm-quinapril-hclhydrochlorothiazide-quinapril-and Source: FDA website
Drug Recall 03-22-22
Orphenadrine citrate
Sandoz announced a voluntary recall of 13 lots of oral orphenadrine citrate 100 mg extended-release tablets due to the presence of an impurity. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-nationwide-recall-13-lots-orphenadrine-citrate-100-mg-extended-release-tablets-due Source: FDA website
Drug Recall 03-23-22
Symjepi
Adamis Pharmaceuticals announced a voluntary recall of certain lots of SymjepiTM (epinephrine injection) due to the potential clogging of the needle preventing the dispensing of epinephrine. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/adamis-pharmaceuticals-corporation-issues-nationwide-voluntary-recall-symjepir-epinephrine-injection Source: FDA website
Drug Recall 03-22-22
Fintepla
The Food and Drug Administration (FDA) approved Fintepla® (fenfluramine oral solution) for the treatment of seizures associated with Lennox-Gastaut syndrome in individuals two years of age and older. Source: FDA website
New Indication 03-25-22
Cabenuva
The Food and Drug Administration (FDA) approved Cabenuva (cabotegravir extended-release injectable suspension and rilpivirine extended-release injectable suspension) for expanded use of every 2-month dosing regimen to include the treatment of human immunodeficiency virus (HIV)-1 infection in adolescents 12 years of age and older and weighing at least 35 kg. Source: FDA website
Expanded Indication 03-29-22
Vocabria and Edurant
The Food and Drug Administration (FDA) approved Vocabria (cabotegravir tablets) for expanded use in combination with Edurant® (rilpivirine tablets) as an oral, short-term treatment regimen followed by Cabenuva injection dosing regimen for the treatment of human immunodeficiency virus (HIV)-1 virus infection in adolescents 12 years of age and older and weighing at least 35 kg. Source: FDA website
Expanded Indication 03-29-22
Tlando
The Food and Drug Administration (FDA) approved TlandoTM (testosterone undecanoate oral capsule) for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Source: FDA website
New Formulation 03-28-22
Triumeq PD
The Food and Drug Administration (FDA) approved Triumeq PD (abacavir/dolutegravir/lamivudine dispersible tablets for oral suspension) for the treatment of pediatric individuals weighing 10 kg to < 25 kg with human immunodeficiency virus type 1 (HIV-1). The original tablet formulation of Triumeq was also expanded to individuals weighing at least 10 kg. Source: FDA website
New Formulation 03-30-22
Idarubicin
Teva Pharmaceuticals announced a voluntary recall of one lot of idarubicin hydrochloride 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/teva-issues-voluntary-nationwide-recall-one-lot-idarubicin-hydrochloride-injection-usp-5-mg5-ml-due Source: FDA website
Drug Recall 03-30-22
North American Custom Laboratories
The Food and Drug Administration (FDA) issued a warning not to use products intended to be sterile produced by North American Custom Laboratories due to a lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-patients-and-health-care-professionals-not-use-sterile-products-north-american-custom?utm_medium=email&utm_source=govdelivery Source: FDA website
Drug Warning 03-31-22
Iodine-containing contrast media
The Food and Drug Administration (FDA) approved a new warning to the prescribing label for the entire class of iodinated contrast media injections and monitoring recommendations for children 3 years or younger. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/iodine-containing-contrast-media-drug-safety-communication-fda-recommends-thyroid-monitoring-babies Source: FDA website
Drug Warning 03-31-22
Yescarta
The Food and Drug Administration (FDA) approved Yescarta® (axicabtagene ciloleucel for intravenous infusion) for adults with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. Source: FDA website
Expanded Indication 04-01-22
Igalmi
The Food and Drug Administration (FDA) approved IgalmiTM (dexmedetomidine sublingual film) for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. Source: FDA website
New Formulation 04-05-22
Vijoice
The Food and Drug Administration (FDA) approved Vijoice® (alpelisib tablets) for the treatment of adult and pediatric individuals 2 years of age and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic therapy. Source: FDA website
New Formulation 04-05-22
Xigduo XR
The Food and Drug Administration (FDA) approved Xigduo® XR (dapagliflozin/metformin extended-release tablet) to reduce the risk of sustained estimated glomerular filtration rate decline, end stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression. Source: FDA website
Expanded Indication 04-11-22
Insulin glargine
Mylan Pharmaceuticals announced a voluntary recall of one batch of insulin glargine injection due to the potential for a missing label. Contact your healthcare provider for questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-conducting-voluntary-nationwide-recall-one-batch-insulin Source: FDA website
Drug Recall 04-13-22
Zerbaxa
The Food and Drug Administration (FDA) approved Zerbaxa® (ceftolozane sulfate/tazobactam sodium injection) in pediatric individuals from birth to less than 18 years of age for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and complicated intra-abdominal infections (cIAI). Source: FDA website
Expanded Indication 04-21-22
Ultomiris
The Food and Drug Administration (FDA) approved Ultomiris® (ravulizumab-cwvz injection) for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. Source: FDA website
New Indication 04-27-22
Epsolay
The Food and Drug Administration (FDA) approved Epsolay® (benzoyl peroxide cream) for the treatment of inflammatory lesions of rosacea in adults. Source: FDA website
New Formulation 04-22-22
Cuvrior
The Food and Drug Administration (FDA) approved CuvriorTM (trientine tetrahydrochloride tablets) for the treatment of adult patients with stable Wilson’s disease who are de-coppered and tolerant to penicillamine. Source: FDA website
New Formulation 04-28-22
Vivjoa
The Food and Drug Administration (FDA) approved VivjoaTM (oteseconazole capsules) to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential. Source: FDA website
New Drug 04-27-22
Camzyos
The Food and Drug Administration (FDA) approved CamzyosTM (mavacamten capsules) for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms. Source: FDA website
New Drug 04-28-22
Accupril
Pfizer announced a voluntary recall of five lots of Accupril due to the presence of a nitrosamine above the acceptable level. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pfizer-voluntary-nationwide-recall-lots-accuprilr-quinapril-hcl-due-n-nitroso-quinapril-content Source: FDA website
Drug Recall 04-23-22
Rinvoq
The Food and Drug Administration (FDA) approved Rinvoq® (upadacitinib extended-release tablets) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. Source: FDA website
New Indication 04-29-22
Olumiant
The Food and Drug Administration (FDA) approved Olumiant® (baricitinib tablets) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Source: FDA approval
New Indication 05-10-22
Qelbree
The Food and Drug Administration (FDA) approved Qelbree® (viloxazine extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in adults aged 18 and older. Source: FDA website
Expanded Indication 05-02-22
Enhertu
The Food and Drug Administration (FDA) approved Enhertu® (fam-trastuzumab deruxtecan-nxki injection) for the treatment of adults with unresectable or metastatic human epidermal growth factor receptor 2 (HER2) positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy. Source: FDA website
Expanded Indication 05-04-22
Ermeza
The Food and Drug Administration (FDA) approved ErmezaTM (levothyroxine sodium oral solution) in adult and pediatric individuals, including neonates, as replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Also approved as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Source: FDA website
New Formulation 04-29-22
Radicava ORS
The Food and Drug Administration (FDA) approved Radicava ORS® (edaravone oral suspension) for the treatment of adults with amyotrophic lateral sclerosis (ALS). Source: FDA website
New Formulation 05-12-22
Mounjaro
The Food and Drug Administration (FDA) approved MounjaroTM (tirzepatide subcutaneous injection) to improve blood sugar control in adults with type 2 diabetes as an addition to diet and exercise. Source: FDA website
New Drug 05-12-22
Voquezna Triple Pak and Voquezna Dual Pak
The Food and Drug Administration (FDA) approved VoqueznaTM Triple PakTM (vonoprazan tablets/amoxicillin capsules/ clarithromycin tablets co-packaged for oral use) and VoqueznaTM Dual PakTM (vonoprazan tablets/amoxicillin capsules/co-packaged for oral use) for the treatment of Helicobacter pylori (H. pylori) infection in adults. Source: FDA website
New Drug 05-03-22
Dupixent
The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) to treat eosinophilic esophagitis (EoE) in adults and pediatric individuals 12 years and older weighing at least 40 kg. Source: FDA website
New Indication 05-20-22
Vidaza
The Food and Drug Administration (FDA) approved Vidaza® (azacitidine injection) for pediatric individuals with newly diagnosed juvenile myelomonocytic leukemia. Source: FDA website
New Indication 05-20-22
Tibsovo
The Food and Drug Administration (FDA) approved Tibsovo® (ivosidenib tablet) in combination with azacitidine for newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Source: FDA website
Expanded Indication 05-25-22
TPOXX
The Food and Drug Administration (FDA) approved TPOXX® (tecovirimat intravenous) for the treatment of human smallpox disease in adults and pediatric individuals weighing at least 3 kg. Source: FDA website
New Formulation 05-18-22
Tyvaso DPI
The Food and Drug Administration (FDA) approved Tyvaso DPI™ (treprostinil oral inhalation) for the treatment of individuals with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). Source: FDA website
New Formulation 05-23-22
Vtama
The Food and Drug Administration (FDA) approved Vtama® (tapinarof topical cream) for the treatment of plaque psoriasis in adults. Source: FDA website
New Drug 05-24-22
Anagrelide
Teva Pharmaceuticals announced a voluntary recall of a single lot of anagrelide capsules due to dissolution test failure. Contact your healthcare provider with details. More details may be viewed at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-issues-voluntary-nationwide-recall-one-lot-anagrelide-capsules-usp-05-mg-due-dissolution-test Source: FDA website
Drug Recall 05-23-22
Evrysdi
The Food and Drug Administration (FDA) approved Evrysdi® (risdiplam oral solution) to include treatment of infants under 2 months old with spinal muscular atrophy (SMA). Source: FDA website
Expanded Indication 05-27-22
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) in combination with fluoropyrimidine- and platinum-containing chemotherapy and Opdivo plus Yervoy (ipilimumab injection) as a first-line treatment for adults with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) regardless of programmed death-ligand 1 (PD-L1) status. Source: FDA website
Expanded Inciation 05-27-22
Kymriah
The Food and Drug Administration (FDA) approved Kymriah® (tisagenlecleucel injection) for the treatment of adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Source: FDA website
Expanded Inciation 05-28-22
Beovu
The Food and Drug Administration (FDA) approved Beovu® (brolucizumab-dbll) for the treatment of diabetic macular edema (DME). Source: FDA website
New Indication 05-27-22
Ukoniq
The Food and Drug Administration (FDA) has withdrawn approval for the cancer medication UkoniqTM (umbralisib tablet) due to safety concerns. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/medical-product-safety-information/ukoniq-umbralisib-drug-safety-communication-fda-approval-lymphoma-medicine-withdrawn-due-safety Source: FDA website
Drug Warning 06-01-22
CellCept
The Food and Drug Administration (FDA) approved CellCept® (mycophenolate mofetil capsule, tablet, oral suspension, and injection) for the prophylaxis of organ rejection in pediatric recipients of allogenic heart and allogenic liver transplants aged 3 months and older in combination with other immunosuppressants. Source: FDA website
Expanded Indication 06-06-22
Dupixent
The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) for the treatment of children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or for when those therapies are not advisable. Source: FDA website
Expanded Indication 06-07-22
Priorix
The Food and Drug Administration (FDA) approved Priorix (measles, mumps, and rubella vaccine, live suspension for subcutaneous injection) for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older. Source: FDA website
New Formulation 06-03-22
Olumiant
The Food and Drug Administration (FDA) approved Olumiant® (baricitinib tablets) for the treatment of adults with severe alopecia areata. Source: FDA website
New Indication 06-13-22
Imcivree
The Food and Drug Administration (FDA) approved ImcivreeTM (setmelanotide subcutaneous injection) for chronic weight management in adult and pediatric individuals 6 years of age and older with obesity due to Bardet-Biedl Syndrome (BBS). Source: FDA website
New Indication 06-16-22
Skyrizi
The Food and Drug Administration (FDA) approved Skyrizi® (risankizumab-rzaa injection) for the treatment of adults with moderately to severely active Crohn's disease. Source: FDA website
New Indication 06-17-22
Amvuttra
The Food and Drug Administration (FDA) approved AmvuttraTM (vutrisiran subcutaneous injection) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Source: FDA website
New Drug 06-13-22
Zulresso
The Food and Drug Administration (FDA) approved ZulressoTM (brexanolone injection for intravenous use) for expansion to include individuals 15 years and older diagnosed with postpartum depression. Source: FDA website
Expanded Indication 06-16-22
Vaxneuvance
The Food and Drug Administration (FDA) approved VaxneuvanceTM (pneumococcal 15-valent conjugate vaccine intramuscular injection) expanded for active immunization for the prevention of invasive disease caused by certain Streptococcus pneumoniae serotypes in individuals 6 weeks of age and older. Source: FDA website
Expanded Indication 06-22-22
Mekinist plus Tafinlar
The Food and Drug Administration (FDA) approved Mekinist® (trametinib tablets) plus Tafinlar® (dabrafenib capsules) for the treatment of adult and pediatric individuals 6 years of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. Source: FDA website
Expanded Indication 06-22-22
Breyanzi
The Food and Drug Administration (FDA) approved Breyanzi® (lisocabtagene maraleucel suspension for intravenous infusion) for the treatment of adults with large B-cell lymphoma (LBCL) after one prior therapy. Source: FDA website
Expanded Indication 06-24-22
Qsymia
The Food and Drug Administration (FDA) approved Qsymia® (phentermine/topiramate extended-release capsules) for chronic weight management in pediatric individuals aged 12 years and older who are obese, defined as a body mass index (BMI) of 95th percentile or greater when standardized for age and sex. Source: FDA website
Expanded Indication 06-24-22
Morphine sulfate
Bryant Ranch Prepack announced a voluntary recall of one lot of morphine sulfate 30 mg extended-release tablets and one lot of morphine sulfate 60 mg extended-release tablets due to incorrect labeling. 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-inc-issues-voluntary-nationwide-recall-morphine-sulfate-30-mg-extended-release Source: FDA website
Drug Recall 06-29-22
Kyprolis
The Food and Drug Administration (FDA) approved Kyprolis® (carfilzomib injection) in combination with Sarclisa® (isatuximab-irfc injection) and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received one to three lines of therapy. Source: FDA website