Amneal Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for memantine/donepezil 14-10mg and 28-10mg extended-release capsules, referencing Abbvie’s Namzaric.
The biopharmaceutical company has also been granted 180-day exclusivity for memantine/donepezil.
The FDA also approved everolimus 2mg, 3mg, and 5mg extended-release capsules, referencing Novartis’ Afinitor Disperz.
Additionally, Amneal received tentative approval for rifaximin 550mg oral tablets, referencing Bausch Health’s Xifaxan, pending litigation.
Memantine/donepezil extended-release capsules, approved for moderate to severe Alzheimer’s dementia, have launched with 180-day exclusivity.
Everolimus tablets for oral suspension are approved for Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA) in patients aged one or older. This also expands the supply of this oncology treatment with limited suppliers.
In adults, rifaximin 550mg oral tablets are approved for treating irritable bowel syndrome with diarrhoea (IBS-D).
Amneal Pharmaceuticals’ Affordable Medicines chief commercial officer and executive vice president Andy Boyer said: “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.
“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.”
Nasdaq-listed Amneal Pharmaceuticals, based in Bridgewater, New Jersey, is engaged in developing, manufacturing, and distributing over 280 generic and speciality drugs, mainly in the US.
Its Affordable Medicines segment focuses on complex products like injectables and biosimilars.
From its speciality segment, the company offers branded pharmaceuticals for the central nervous system and endocrine disorders, with a pipeline targeting unmet needs.
Through its AvKARE segment, Amneal distributes pharmaceuticals to the US federal government, retail, and institutional markets.
In November last year, the biopharmaceutical company secured FDA approval for exenatide, a generic injectable glucagon-like peptide-1 (GLP-1) agonist.
