Amylin Pharmaceuticals Inc. (AMLN)

[surf1944]

5:00PM Amylin, Lilly and Alkermes submit reply to FDA complete response letter for BYDUREON (AMLN) 20.54 -0.31 : Amylin Pharmaceuticals (AMLN), Eli Lilly and Company (LLY) and Alkermes (ALKS) announced that the companies have submitted their reply to a complete response letter issued last month by the FDA after review of the New Drug Application submission for BYDUREON (exenatide for extended-release injectable suspension). In accordance with its guidelines, the FDA is expected to classify the complete response as a Class 1 or Class 2 resubmission, and also provide the companies with an updated Prescription Drug User Fee Act target action date within the next two weeks. The companies' reply addresses requests from the FDA primarily related to finalization of the product labeling with accompanying Risk Evaluation and Mitigation Strategy and clarification of existing manufacturing processes.