Breaking News, Trials & Filings

Boehringer, Lilly Get Complete Response Letter for Empagliflozin

FDA is unable to approve sNDA for Empagliflozin in type 1 diabetes

Author Image

By: Kristin Brooks

Managing Editor, Contract Pharma

The U.S. FDA has issued a complete response letter for the supplemental New Drug Application (sNDA) of the investigational medicine empagliflozin 2.5 mg as an adjunct to insulin for adults with type 1 diabetes. Empagliflozin 2.5 mg is being developed by Boehringer Ingelheim and Eli Lilly and Co. The letter indicates that the FDA is unable to approve the application in its current form, consistent with the outcome of the Endocrinologic and Metabolic Drugs Advisory Committee in November. &#8...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters