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Eli Lilly and Company (LLY) Says New Drug Application Rejected On Facility Issues



3/5/2014 8:19:13 AM

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Eli Lilly LLY & Co. said the U.S. Food and Drug Administration won't approve its new drug application for a type-2 diabetes treatment until issues at the product manufacturing facility are resolved. Lilly said Wednesday that it received a complete response letter from the FDA that referenced deficiencies at the Boehringer Ingelheim Pharmaceutical Inc. facility where its diabetes treatment, empagliflozin, will be manufactured. A spokesperson for the FDA wasn't available for comment.

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