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Product safetyFDAUnited StatesImports

Determination That ISTURISA (Osilodrostat) Tablets, 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

30 September 2026

In plain English

FDA has determined that ISTURISA (osilodrostat) tablets, 10 milligrams, were not withdrawn for safety or effectiveness reasons, allowing approval of ANDAs for that strength if other requirements are met.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
30 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

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Administration (FDA, Agency, or we) has determined that ISTURISA (osilodrostat) tablets, 10 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness.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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