Eli Lilly and Co.; Withdrawal of Approval of a New Drug Application for ORAFLEX

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The Food and Drug Administration (FDA) is withdrawing approval of a new drug application (NDA) for ORAFLEX (benoxaprofen) Tablets, held by Eli Lilly and Co. (Lilly), Lilly Corporate Center, Indianapolis, IN 46285. Lilly has voluntarily requested that approval of this application be withdrawn, and has waived its opportunity for a hearing.