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FDA Issues Warning Letter to Eli Lilly & Co.
September 17, 2025

WASHINGTON, Sept. 17 -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following warning letter to Eli Lilly and Co. from the Center for Drug Evaluation and Research:

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Recipient: David A. Ricks, Chief Executive Officer, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, United States

Issuing Office: Center for Drug Evaluation and Research (CDER), United States

RE: NDA 217806 and . . .

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