Abecma
The FDA has approved Abecma (idecabtagene vicleucel) as the first B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy for the treatment of adult patients 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.
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Arcalyst
The FDA has approved Arcalyst (rilonacept). This weekly, subcutaneously-injected recombinant fusion protein blocks interleukin-1 alpha and interleukin-1 beta signaling to treat recurrent pericarditis and reduce risk of recurrence in adults and children aged 12 years and older. The commercial launch is expected in April 2021.
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Fotivda
The FDA has approved Fotivda (tivozanib) for the treatment of adults with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. Fotivda is an oral, next-generation vascular endothelial growth factor tyrosine kinase inhibitor.
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Ponvory
The FDA has approved Ponvory (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 modulator, to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
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Roszet
The FDA has approved Roszet (ezetimibe/rosuvastatin) tablets, for oral use. Roszet is indicated in adults as an adjunct to diet in patients 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 patients with homozygous familial hypercholesterolemia to reduce LDL-C.
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Zegalogue
The FDA has approved Zegalogue (dasiglucagon) injection for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above. Zegalogue will be available in both an autoinjector and a prefilled syringe.
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Actemra
The FDA has approved Actemra (tocilizumab) subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease, a debilitating condition with limited treatment options. Actemra is the first biologic therapy approved by the FDA for the treatment of the disease. This is the sixth FDA-approved indication for Actemra.
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Myrbetriq
The FDA has approved Myrbetriq (mirabegron extended-release tablets) for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged three years and older who weigh 35kg or more, and Myrbetriq Granules (mirabegron for extended-release oral suspension) for the treatment of NDO) in pediatric patients aged three years and older. The FDA also granted pediatric exclusivity for Myrbetriq, resulting in an additional six-month period of market exclusivity.
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Praluent
The FDA has approved Praluent (alirocumab) injection for adult patients with homozygous familial hypercholesterolemia (HoFH), a genetic condition that causes severely high cholesterol. Praluent is not intended to be used alone but instead added to other treatments for HoFH.
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Sarclisa
The FDA has approved Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy. This is the second FDA approval for Sarclisa in combination with standard of care backbone therapies.
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Alembic Pharmaceuticals Telmisartan Tablets
Alembic Pharmaceuticals is voluntarily recalling one lot of telmisartan tablets, USP, 20mg, packaged in 30-count bottles, Lot No. 1905005661 to the consumer level. The product is being recalled due to a market complaint received which stated that one bottle labeled as 30-count telmisartan tablets, USP, 20mg incorrectly contained 30 tablets of telmisartan tablets, USP, 40mg.
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Antoto-K Thumbs Up 7
Antoto-K is voluntarily recalling all lots of Thumbs Up 7 Red 70K, 10 capsules to consumer level. FDA analysis has found the product to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil in Thumbs Up 7 Red 70K, 10 capsules makes them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.
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Apotex Corp. Guanfacine
Apotex Corp is voluntarily recalling three lots of guanfacine extended-release tablets 2mg to the consumer level due to trace amounts of quetiapine fumarate in one lot RX1663. Out of an abundance of caution, lots RX1662 and RX1664 are also included in the scope of this voluntary recall, as they were manufactured in the same campaign as lot RX1663.
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Bit & Bet Thumbs Up 7
Bit & Bet is voluntarily recalling all lots of Thumbs Up 7 Blue 69K capsules to consumer level. FDA analysis has found the product to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil in Thumbs Up 7 Blue 69K capsules make them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.
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Bryant Ranch Prepack Spironolactone Tablets
Bryant Ranch Prepack is voluntarily recalling in total 47 bottles of spironolactone tablets (four different lots) to the consumer level. The products have been found to be mislabeled, displaying the incorrect strength. Prepackaged bottles labeled spironolactone 50mg may contain spironolactone 25mg tablets, and prepackaged bottles of spironolactone 25mg may contain spironolactone 50mg tablets.
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Durisan Hand Sanitizer
Durisan announced a voluntary recall of multiple lots of Durisan Antimicrobial Hand Sanitizer, Non-Alcohol products in various sizes. The products are being recalled due to microbial contamination.
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Heal the World Hand Sanitizer
Heal the World is voluntarily recalling all lots of Heal the World hand sanitizer packaged in 9.6 fl. oz containers, to the consumer level. The products are being recalled because they resemble 9.6-ounce water bottles.
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Namoo Enterprise PremierZen
Namoo Enterprise is voluntarily recalling all lots within expiry of PremierZen Black 5000 capsules to the consumer level. FDA analysis has found the product to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil in PremierZen Black 5000 products makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall.
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NANA Collection PremierZen Platinum 5000 and Triple SupremeZen Gold 3500
NANA Collection is voluntarily recalling all lots of PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 to the consumer level. FDA analysis has found the PremierZen Platinum 5000 to contain undeclared tadalafil and Triple SupremeZen 3500 to contain undeclared tadalafil and sildenafil. The presence of tadalafil and sildenafil in these products renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.
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Nuri Trading LLC Thumbs Up 7, Shogun-X, and 69MODE
Nuri Trading is voluntarily recalling all lots within expiry of Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, and 69MODE Blue 69 capsules to the consumer level. FDA analyses have found these products to contain undeclared tadalafil, sildenafil, and/or vardenafil. The presence of sildenafil, tadalafil, and/ or vardenafil in these products make them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.
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S&B Shopper Imperial
S&B Shopper is voluntarily recalling all lots of Imperial Extreme 2000mg capsules, to the consumer level. FDA analysis has found this product to contain undeclared sildenafil and tadalafil.
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Sagent Pharmaceuticals Phenylephrine Hydrochloride Injection
Sagent Pharmaceuticals announced the voluntary nationwide recall of three lots of phenylephrine hydrochloride injection, USP (10mg/mL). This product was manufactured by Indoco Remedies Ltd. and distributed by Sagent Pharmaceuticals, Inc. Sagent has initiated this voluntary recall of phenylephrine hydrochloride injection, USP to the user level as the result of a customer complaint due to potentially loose crimped vial overseals. A non-integral crimped vial overseal may result in a non-sterile product.
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Ummzy Thumbs Up 7, Shogun, and Krazy Night
Ummzy is voluntarily recalling all lots of Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night capsules to consumer level. FDA analysis has found the product to contain undeclared tadalafil, sildenafil, and vardenafil. The presence of tadalafil, sildenafil, and vardenafil in these products makes them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.
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Zydus Pharmaceuticals Acyclovir Sodium Injection
Zydus Pharmaceuticals is voluntarily recalling four lots of acyclovir sodium injection, 50mg/mL, 10mL and 20mL vials, to the hospital/user level after receiving several complaints of crystallization in vials. Zydus Pharmaceuticals has not received any reports of adverse events related to this product recall.
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