2023-13733: Gemini Laboratories, LLC, et al.; Withdrawal of Approval of One New Drug Application for OXANDRIN (Oxandrolone) Tablets and Four Abbreviated New Drug Applications for Oxandrolone Tablets
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The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) for OXANDRIN (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, held by Gemini Laboratories, LLC (Gemini). Gemini voluntarily requested withdrawal of this application and waived its opportunity for a hearing. In addition, FDA is withdrawing approval of four abbreviated new drug applications (ANDAs) for oxandrolone tablets from multiple ANDA holders. Upsher-Smith Laboratories, LLC (Upsher- Smith), Par Pharmaceutical, Inc. (Par), and Sandoz Inc. (Sandoz) voluntarily requested withdrawal of their respective applications and waived their opportunity for a hearing.
The agency’s own summary, as published.
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