Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction
By Health, Drug Administration, Human Services Department, Food · Oct 6, 2026, 11:00 PM CDT
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of September 13, 2023 (88 FR 62799). The notice announced the determination that Oxandrin (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, were withdrawn from sale for reasons of safety or effectiveness. The notice did not include the determination that the abbreviated new drug applications (AN
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Layer 1 · Claims & fact checks
AI analysisLayer 3 · Reporting analysis
AI analysisCorrectiveThe statement frames the article as an amendment to a prior official notice, emphasizing accuracy and completeness.
FactualProvides the core factual claim about the withdrawal decision.
ClarifyingAdds missing detail to the original notice, specifying the impact on ANDAs and the Orange Book.
Context
AI analysisMissing context
The notice does not explain the specific safety or effectiveness concerns that led to the withdrawal, nor does it provide details about the impact on patients or prescribers.
Important context
The correction ensures that both the drug products and their associated ANDAs are officially recorded as withdrawn, affecting their status in the FDA’s Orange Book, which clinicians use to assess therapeutic equivalence.
Opinion vs. reporting
AI analysisThe text is purely factual and corrective; it does not contain opinion or editorial commentary.