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FDA sets January action date for Bydureon

August 11, 2011 12:11 AM UTC

FDA accepted an NDA resubmission from Amylin Pharmaceuticals Inc. (NASDAQ:AMLN) for Type II diabetes candidate once-weekly Bydureon exenatide. The agency designated the NDA a Class 2 resubmission, with a PDUFA date of Jan. 28, 2012. Amylin and Eli Lilly and Co. (NYSE:LLY) developed Bydureon, which uses drug delivery technology from Alkermes Inc. (NASDAQ:ALKS). The partners made the announcement after market close. Amylin was down $0.78 to $9.69 on Wednesday. Alkermes slid $0.83 to $13.91. ...