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Amneal Receives U.S. FDA Approval for Memantine/Donepezil Extended-Release Capsules and Everolimus Tablets for Oral Suspension, and Tentative U.S. FDA Approval for Rifaximin
Approval of three important therapies for dementia, oncology and gastrointestinal disease Granted 180-day exclusivity for memantine/donepezil
About this update from Amneal Pharmaceuticals, Inc.
[{"type":"text","content":"\nApproval of three important therapies for dementia, oncology and gastrointestinal disease\n\n\nGranted 180-day exclusivity for memantine/donepezil extended-release capsules\n\n\nTentative approval of rifaximin, a product for treating IBS-D\n\n\n BRIDGEWATER, N.J.--(BUSINESS WIRE)--\nAmneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved memantine/donepezil 14-10 mg and 28-10 mg extended-release capsules, which references Abbvie’s NAMZARIC®, and Everolimus 2 mg, 3 mg and 5 mg extended-release capsules, which references Novartis’ AFINITOR DISPERZ®. In addition, the FDA has granted tentative approval to Amneal’s rifaximin 550 mg oral tablets, which references Bausch Health’s XIFAXAN®. The FDA approval was tentative as this product is involved in litigation.\n\n\nMemantine/donepezil extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. The product has launched with 180-day exclusivity.\n\n\nEverolimus tablets for oral suspension are indicated for the treatment of Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA) in adult and pediatric patients aged one year or older. This launch increases the supply of an oncology product that has limited suppliers.\n\n\nRifaximin 550 mg oral tablets are indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.\n\n\n“Amneal’s competitive advantage in the Affordable Medicines business remains our core capabilities to drive innovation at scale across complex categories to expand the breadth and depth of our portfolio,” said Andy Boyer, Executive Vice President, Chief Commercial Officer, Affordable Medicines. “With our 180-day exclusivity on memantine/donepezil, increasing supply for everolimus, and the tentative approval of rifaximin, we are continuing to expand our differentiated portfolio and providing new key therapies for our customers, providers and patients.”\n\n\nThe most common adverse reactions with memantine hydrochloride were headache, diarrhea, and dizziness. The most common adverse reactions occurring in patients receiving donepezil include diarrhea, anorexia, vomiting, nausea, and bruising. For complete prescribing information, see package insert available here.\n\n\...