Amylin Pharmaceuticals Inc. (AMLN), Eli Lilly and Co. (LLY) and Alkermes Inc. (ALKS) announced that the U.S. Food and Drug Administration has classified the BYDUREON, or exenatide for extended-release injectable suspension, complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act or PDUFA action date of October 22, 2010.
"If approved, BYDUREON will be the first once-weekly treatment for type 2 diabetes, and we are committed to making this important therapeutic option available to patients as soon as possible," said Orville Kolterman, senior vice president of research and development, Amylin Pharmaceuticals.
The new drug application for BYDUREON was submitted in May 2009 and was based on data from the DURATION clinical trial program, as well as more than seven years of clinical experience with BYETTA (exenatide) injection.
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