FDA Classifies Bydureon Complete Response as a Class 2 Resubmission

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Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. announced that the U.S. Food and Drug Administration has classified the Bydureon(TM) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010.

Bydureon (pronounced by-DUR-ee-on) is the proposed brand name for exenatide once weekly. It is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous therapeutic levels of exenatide – the active ingredient in Byetta – in a single weekly dose.  Byetta, the first FDA-approved GLP-1 receptor agonist for the treatment of type 2 diabetes, has been available in the U.S. since June 2005 and is used in approximately 60 countries worldwide to improve glycemic control in adults with type 2 diabetes.

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