Type 2 diabetes: Boehringer Ingelheim and Eli Lilly and Company announce resubmission of New Drug Application for empagliflozin to FDA (NYSE:LLY)

RIDGEFIELD, Conn. and INDIANAPOLIS, June 17, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY) today announced the resubmission of a New Drug Application (NDA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin for the treatment of adults with type 2 diabetes (T2D) to the U.S. Food and Drug Administration (FDA). The Class 1 resubmission follows a complete response letter issued by the FDA that referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. The FDA did not ask Boehringer Ingelheim to complete any new clinical trials to support the approval of the application.



Type 2 diabetes: Boehringer Ingelheim and Eli Lilly and Company announce resubmission of New Drug Application for empagliflozin to FDA (NYSE:LLY)