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Amneal Set To Debut US Byetta Competition – Two Decades After Market Entry

One Of First GLP-1 Generics To Receive US FDA Approval; Follows Recent Liraglutide AG

 
• By Dean Rudge

The first GLP-1 agonist to receive US Food and Drug Administration approval, Byetta (exenatide), has generic competition at last, with Amneal bagging the first rival after Teva seemingly abandoned its proposed generic version.

Diabetes
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Amneal has welcomed US Food and Drug Administration approval for the first-and-only US generic version of AstraZeneca’s Byetta (exenatide) type 2 diabetes treatment – the US-based firm’s first glucagon-like peptide-1 (GLP-1) agonist approval that, Amneal says, “reflects the company’s deep innovation and regulatory capabilities in complex pharmaceuticals.”

“Exenatide is a peptide drug-device combination product that is complex to develop and make. Amneal is leveraging its leading product development and manufacturing capabilities in the rapidly growing GLP-1 therapeutic...

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More from Generics Bulletin

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ANI Pharmaceuticals says it has delivered an “exceptionally strong first quarter,” with total sales reaching over $197m, amid plans to kick off a Phase IV clinical trial for Cortrophin Gel for acute gouty arthritis later this year.

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