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FDA gives Amneal permission for 2 new generics, tentative OK for generic Xifaxan

The approvals provide therapies for dementia, oncology and gastrointestinal disease.
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fda approved

Amneal has received the Food and Drug Administration’s approval for two new generics and tentative approval for another generic.

The FDA has approved memantine/donepezil 14-10 mg and 28-10 mg extended-release capsules, which is the generic of Abbvie’s Namzaric.

Also permitted was Amneal’s everolimus 2 mg, 3 mg and 5 mg extended-release capsules, which is the generic of Novartis’ Afinitor Disperz. 

In addition, the FDA has granted tentative approval to Amneal’s rifaximin 550 mg oral tablets, which is the generic of Bausch Health’s Xifaxan. The FDA approval was tentative as this product is involved in litigation.

[Related: Amneal touts 39 retail, injectable product launches in 2023]

Memantine/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.

Everolimus tablets for oral suspension are indicated for the treatment of Tuberous Sclerosis Complex-Associated Subependymal Giant Cell Astrocytoma in adult and pediatric patients aged one year old or older. This launch increases the supply of an oncology product that has limited suppliers, Amneal noted.

Rifaximin 550 mg oral tablets are indicated for the treatment of irritable bowel syndrome with diarrhea in adults. 

“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 at Amneal. “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.”

[Read more: Amneal touts 26 generic new product launches in 2022]

Memantine/donepezil tablets, everolimus tablets and rifaximin tablets had a market value for the 12 months ended November 2024, of approximately $88 million, $114 million and $2.6 billion (for all approved indications of Xifaxan), respectively, per IQVIA.

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