2023-10924: Abbott Laboratories Pharmaceutical Products Division; Withdrawal of Approval of New Drug Applications for CYLERT (Pemoline) Tablets, 18.75 Milligrams, 37.5 Milligrams, and 75 Milligrams, and CYLERT (Pemoline) Chewable Tablets, 37.5 Milligrams
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The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) 016832 for CYCLERT (pemoline) tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, as well as NDA 017703 for CYCLERT (pemoline) chewable tablets, 37.5 mg, held by Abbott Laboratories Pharmaceutical Products Division, c/o G&L Scientific, 25 Independence Blvd., 4th Floor, Warren, NJ 07059 (Abbott). Abbott requested that approval of these applications be withdrawn and has waived its opportunity for a hearing.
The agency’s own summary, as published.
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