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2026-09-30 · Notice · Federal Register document 2026-19968

Determination That ISTURISA (Osilodrostat) Tablets, 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Health and Human Services Department, Food and Drug Administration

Official abstract: The Food and Drug Administration (FDA, Agency, or we) has determined that ISTURISA (osilodrostat) tablets, 10 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for osilodrostat tablets, 10 mg if all other legal and regulatory requirements are met.

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