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Amylin Pharmaceuticals, Lilly and Alkermes received a complete response letter from the FDA for their NDA for Bydureon (exenatide extended-release injectable suspension).
March 15, 2010
By: Tim Wright
Editor-in-Chief, Contract Pharma
Amylin Pharmaceuticals, Lilly and Alkermes received a complete response letter from the FDA for their NDA for Bydureon (exenatide extended-release injectable suspension). Bydureon is an investigational, extended-release medication for type 2 diabetes designed to deliver continuous levels of exenatide in a single weekly dose. The letter requested the finalization of the product labeling along with Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing proces...
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