Amylin, Lilly and Alkermes Receive Complete Response Letter From FDA for Exenatide Once Weekly Submission

March 15, 2010 by Rx Times
Filed under Rx News, Rx Trials

SAN DIEGO, INDIANAPOLIS, and WALTHAM, Mass., March 15, 2010 - Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON(TM) (exenatide for extended-release injectable suspension).
In the [...]

Tags: Alkermes, Amylin Pharmaceuticals, Bydureon, Eli Lilly and Company, Lilly