Eli Lilly, Boehringer Diabetes Drug Faces FDA Roadblock

Law360, New York (March 5, 2014, 5:35 PM EST) -- The U.S. Food and Drug Administration has said it observed “deficiencies” at the site where a new diabetes drug developed by Boehringer Ingelheim Pharmaceuticals Inc. and Eli Lilly and Co. will be made, the companies said Wednesday, a potential roadblock to the drug’s approval.

The FDA replied to Boehringer and Eli Lilly's new drug application with a complete response letter that said it had seen problems at the facility where the Type 2 diabetes drug empagliflozin will be manufactured, the companies said. The FDA letter told...
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