2026-20503: Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness; Correction
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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 The notice announced the determination that Oxandrin (oxandrolone) tablets, 2.5 milligrams (mg) and 10 mg, were withdrawn from sale for reasons of safety or effectiveness.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new drug applications (ANDAs) referencing Oxandrin (oxandrolone) tablets, 2.5 mg and 10 mg, were also determined to be withdrawn from sale for reasons of safety or effectiveness and that these ANDAs would be removed from "Approved Drug Products With Therapeutic Equivalence Evaluations," which is known generally as the "Orange Book." This notice corrects that error.
The agency’s own summary, as published.
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