Amneal Pharmaceuticals (AMRX) said Thursday that the US Food and Drug Administration (FDA) has approved three major therapies for dementia, oncology, and gastrointestinal disease.
The company said the FDA approved memantine/donepezil extended-release capsules for treating moderate to severe Alzheimer's dementia, referencing AbbVie's (ABBV) Namzaric, and that the drug has launched with 180-day exclusivity.
The drugmaker said the FDA also approved everolimus extended-release capsules for treating tuberous sclerosis complex-associated subependymal giant cell astrocytoma in adults and children aged one year and up.
The company said the launch increases the availability of an oncology product with limited suppliers, referencing Novartis' (NVS) Afinitor Disperz.
Additionally, the company said the health agency granted tentative approval for rifaximin oral tablets, which treat irritable bowel syndrome with diarrhea in adults.
The tentative approval is due to ongoing litigation, as the company said the product references Bausch Health's (BHC) Xifaxan.
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