03.15.10
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 processes. There were no requests for new clinical trials and the letter does not include the December 2009 observations from the FDA's pre-approval inspection at the Ohio manufacturing facility, as those observations have been addressed.
"This is a significant step forward in our ability to bring this important therapy to patients," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "We have a clear path forward and are working diligently to submit our response to the FDA in the next few weeks."
The NDA was submitted in May 2009 and accepted by the FDA in July 2009.
The letter requested the finalization of the product labeling along with Risk Evaluation and Mitigation Strategy (REMS) and clarification of existing manufacturing processes. There were no requests for new clinical trials and the letter does not include the December 2009 observations from the FDA's pre-approval inspection at the Ohio manufacturing facility, as those observations have been addressed.
"This is a significant step forward in our ability to bring this important therapy to patients," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "We have a clear path forward and are working diligently to submit our response to the FDA in the next few weeks."
The NDA was submitted in May 2009 and accepted by the FDA in July 2009.