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News Breaks
March 5, 2014
09:34 EDTLLYFDA issues complete response letter for Empagliflozin to Boehringer, Lilly
Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company announced the U.S. Food and Drug Administration has issued a complete response letter for the New Drug Application of the investigational sodium glucose co-transporter-2 inhibitor empagliflozin.The complete response letter referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured. The FDA stated these deficiencies need to be resolved before the approval of the application. The FDA has not asked Boehringer Ingelheim to complete any new clinical trials to support the approval of the application.Boehringer Ingelheim and Lilly are committed to working with the FDA to make empagliflozin available to adults with type 2 diabetes and submitting a response to the complete response letter as soon as possible. The U.S. NDA was based on results from one of the largest clinical registration programs in its class, comprised of more than 10 multinational clinical trials and more than 13,000 people with type 2 diabetes.
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