Eli Lilly Plans a Response on Bydureon This Week, Estimates Health Reform Costs

Eli Lilly and its partners plan to submit a response this week to the FDA’s complete response letter on once-weekly diabetes drug Bydureon. Last month, Lilly, Alkermes and Amylin Pharmaceuticals received a complete response letter requesting final labeling information and a risk evaluation and mitigation strategy for Bydureon (exenatide). The drug also is under review by the European Medicines Agency, the company said.
Drug Industry Daily