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Aug 01, 2011
 |  BC Week In Review  |  Clinical News  |  Regulatory

Bydureon exenatide once weekly regulatory update

Amylin submitted a reply to a complete response letter from FDA for Type II diabetes candidate once-weekly Bydureon exenatide. Amylin and partner Eli Lilly expect the agency to classify the response as a Class 2 resubmission, with a 6-month review. A new PDUFA date...

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