Federal Register #2026-19968

FDA Regulatory Determination for ISTURISA (Osilodrostat) 10 mg Tablets

This FDA notice addresses the regulatory status of ISTURISA, rather than a government purchase. - Government agency: U.S. Department of Health and Human Services, Food and Drug Administration (FDA). - Regulatory determination: ISTURISA (osilodrostat) tablets, 10 mg, was not withdrawn from sale for reasons of safety or effectiveness. - Named organizations: Recordati Rare Diseases, Inc. is the holder of NDA 212801; Annora Pharma Private Limited submitted the citizen petition. - Product status: FDA will continue listing the drug in the Orange Book’s Discontinued Drug Product List. Abbreviated New Drug Applications (ANDAs) for osilodrostat tablets, 10 mg, may be approved if they meet all other applicable legal and regulatory requirements. - Procurement status: This is a regulatory notice, not a solicitation or purchase request. No quantities, contract period, or procurement line items are specified.

Description

The FDA determined that ISTURISA (osilodrostat) tablets, 10 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination allows FDA to approve abbreviated new drug applications (ANDAs) for osilodrostat tablets, 10 mg, if all other legal and regulatory requirements are met. Annora Pharma Private Limited submitted the citizen petition requesting this determination. The notice states that ISTURISA will remain listed in the Orange Book’s Discontinued Drug Product List.

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