Eli Lilly & Co. and Boehringer Ingelheim GMBH are working to submit a reply to an FDA “complete response” letter for their empagliflozin NDA as soon as possible, but in the highly competitive diabetes market, the delay could come at a high commercial cost.
Manufacturing Woes Result In “Complete Response” For Lilly’s Empagliflozin
Some analysts expect it could take six months to resolve problems at partner Boehringer Ingelheim’s German manufacturing site, where the SGLT-2 inhibitor is made. Lilly says the European filing is not affected.
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