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Amneal Celebrates FDA Approvals For Generic Namzaric And Afinitor Disperz

Also, Tentative Approval For Off-Patent Rival To Xifaxan Due To Ongoing Litigation

 
• By Urtė Fultinavičiūtė

Amneal builds on its affordable medicines business with three FDA approvals – two final and one tentative – for generic rivals referencing AbbVie’s Namzaric, Novartis’ Afinitor Disperz, and Bausch Health’s Xifaxan.

Stamp saying approved
(Shutterstock)

Amneal has snatched US Food and Drug Administration approval for and launched its generic rival to AbbVie’s Namzaric (memantine/donepezil) extended-release capsules, with the agency also granting 180-day market exclusivity.

The drug, which was approved in 14mg/10mg and 28mg/10mg doses, is indicated to treat moderate to severe dementia due the...

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