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December 23, 2019

Caplyta Receives Approval for Schizophrenia

December 23, 2019 –The U.S. FDA has approved Caplyta® (lumateperone), manufactured by Intra-Cellular Therapies, to treat schizophrenia in adults. Caplyta is an atypical antipsychotic with a unique mechanism of action that targets three different neurotransmitters in the brain – serotonin, dopamine

December 20, 2019

Enhertu Approved to Treat Breast Cancer

December 20, 2019 – The U.S. FDA has approved Enhertu® (fam-trastuzumab deruxtecan-nxki), manufactured by Daiichi Sankyo, to treat adult patients who have unresectable or metastatic HER2- positive breast cancer and have been treated with at least two prior anti-HER2-based regimens in the

December 20, 2019

Lannett Company Voluntarily Recalls Seizure Medication

December 20, 2019 – Lannett Company, Inc., has issued a voluntary recall of two lots of Levetiracetam Oral Solution 100mg/mL due to contamination with Bacillus subtilis identified during evaluation of a raw material used to manufacture the product. Bacillus subtilis is a bacterium regularly found in the

December 19, 2019

First Ebola Vaccine Approved

December 19, 2019 – The U.S. FDA has approved Ervebo® (Ebola Zaire Vaccine, Live) manufactured by Merck. It is the first vaccine in the world approved to prevent disease caused by Zaire ebolavirus, one of the organisms responsible for causing Ebola virus disease (EVD). The vaccine is indicated for use in

December 19, 2019

FDA Safety Communication for Gabapentin and Pregabalin

December 19, 2019 – The U.S. FDA has issued a warning that serious breathing difficulties may occur in patients who have respiratory risk factors and use the medications gabapentin or pregabalin. Risk factors include advanced age, respiratory diseases such as chronic obstructive pulmonary disease (COPD) that

December 19, 2019

Arazlo Approved to Treat Acne

December 19, 2019 – The U.S. FDA has approved ArazloTM (tazarotene) lotion 0.045%, manufactured by Ortho Dermatologics. The product is indicated to provide topical treatment of acne vulgaris in patients who are at least nine years of age. Although the active ingredient has been FDA approved since 1997

December 18, 2019

Padcev Approved to Treat Bladder Cancer

December 18, 2019 – The U.S. FDA has granted accelerated approval to PadcevTM (enfortumab vedotin- ejfv), manufactured by Astellas and Seattle Genetics, to treat adult patients who have locally advanced or metastatic urothelial cancer. Patients must have already been treated with a platinum

December 18, 2019

Glenmark Recalls Prescription Ranitidine

December 18, 2019 – Glenmark Pharmaceuticals has halted distribution of both its 150mg and 300mg prescription ranitidine tablets due to the potential for N-nitrosodimethylamine (NDMA) levels in excess of the FDA’s currently established limits. The company has also recalled all unexpired lots on the United