Opportunity
Federal Register #2026-20503
FDA correction clarifies safety-related withdrawal of Oxandrin tablets and associated generic drug applications
Buyer
Food and Drug Administration
Posted
October 07, 2026
Identifier
2026-20503
The FDA notice clarifies the safety-related withdrawal of Oxandrin tablets and associated generic drug applications. - Government agency: U.S. Department of Health and Human Services, Food and Drug Administration (FDA). - Products discussed: Oxandrin (oxandrolone) tablets in 2.5 mg and 10 mg strengths; this is a regulatory notice, not a request to purchase products or services. - Affected application holders named: Par Pharmaceutical Inc., Roxane Laboratories, Inc., Sandoz Inc., and Upsher-Smith Laboratories LLC. Gemini is also mentioned in connection with the original new drug application. - Regulatory action: The FDA clarifies that abbreviated new drug applications referencing the tablets were also determined to be withdrawn for safety or effectiveness reasons and will be removed from the Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book). - Procurement details: No requested quantities, part numbers, services, or contract performance period are provided.
Description
The FDA notice corrects a notice published on September 13, 2023, concerning Oxandrin (oxandrolone) tablets in 2.5 mg and 10 mg strengths. It adds that abbreviated new drug applications referencing these tablets were also determined to be withdrawn from sale for reasons of safety or effectiveness. The correction further states that the relevant ANDAs will be removed from the FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book).