The FDA has accepted Otsuka’s New Drug Application for centanafadine, a first-in-class norepinephrine, dopamine and serotonin reuptake inhibitor (NDSRI) for the treatment of attention-deficit ...
(RTTNews) - Mahwah, New Jersey-based Glenmark Pharmaceuticals Inc., USA is recalling 114 batches of Potassium Chloride Extended-Release Capsules USP (750 mg) 10 mEq K citing failed dissolution, ...
The Prescription Drug User Fee Act target action date for the NDA is scheduled for 24 July 2026.
BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved ...
Please provide your email address to receive an email when new articles are posted on . Crexont was associated with about a half an hour more of “good on” time per day compared with immediate release ...
Two brands of potassium chloride capsules are being recalled because they may not dissolve as they should, which could cause a person to have a heart attack, according to the Food and Drug ...
Ketoprofen 200mg; pH-dependent coated pellets in caps. Ketoprofen is a nonsteroidal anti-inflammatory drug with analgesic and antipyretic properties. In anti-inflammatory models ketoprofen has been ...
Please provide your email address to receive an email when new articles are posted on . The FDA has granted tentative approval to Zydus Pharmaceuticals Inc. to market extended-release capsules of ...
Amneal to hold CREXONT launch symposium and scientific presentations at the International Congress of Parkinson’s Disease and Movement Disorders on Sept. 27 – Oct. 1, 2024 “We are pleased to launch ...