Amylin Pharmaceuticals Inc. (AMLN)

[surf1944]

6:15AM Amylin Pharma, Eli Lilly and Alkermes receive complete response letter from FDA for exenatide once weekly submission (AMLN) 20.26 : Co, Eli Lilly (LLY) and Alkermes (ALKS) announce that the FDA has issued a complete response letter regarding the New Drug Application for BYDUREON. In the complete response letter there are no requests for new pre-clinical or clinical trials. Requests raised in the letter primarily relate to the finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy and clarification of existing manufacturing processes. The complete response letter does not contain requests related to the December 2009 observations from the FDA's pre-approval inspection at the Ohio manufacturing facility. All of those observations have been addressed.