Amneal Pharmaceuticals Inc. (AMRX), a biopharmaceutical company, announced, on Thursday, that it has secured FDA approval for Memantine/donepezil extended-release capsules and Everolimus tablets for oral suspension, as well as tentative FDA approval for Rifaximin.
The company's memantine/donepezil 14-10 mg and 28-10 mg extended-release capsule, which references Abbvie's NAMZARIC, is approved for the treatment of moderate to severe dementia of the Alzheimer's type. The product carries a 180-day exclusivity.
The Everolimus tablet for oral suspension, which references Novartis' AFINITOR DISPERZ, is 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.
Rifaximin, which has been granted tentative approval in the U.S., references Bausch Health's XIFAXAN, and is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. Amneal's Rifaximin is at the center of a patent dispute with Bausch Health, which is why it has received only tentative approval in the U.S.
These approvals enhance Amneal's portfolio across several therapeutic areas, providing critical therapies in dementia, oncology, and gastrointestinal diseases.
Currently, AMRX is trading at $8.43 down by 1.06%.
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