Amylin, Eli Alkermes and Lilly answer FDA complete response letter for BYDUREON NDA Amylin Pharmaceuticals, Inc. , Eli Lilly and Organization and Alkermes, Inc vĂ©rifier les informations suivantes . today announced that the firms have submitted their reply to a comprehensive response letter released last month by the U.S. Relative to its suggestions, the FDA is expected to classify the entire response as a Class 1 or Course 2 resubmission, and in addition provide the companies with an up to date Prescription Drug User Fee Act target action date within the next two weeks. The FDA’s full response letter didn’t request new pre-clinical or clinical trials, nor did it contain requests linked to the December 2009 observations from the FDA’s pre-acceptance inspection at the Ohio manufacturing unit.

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