FDA Okays Generics for ISTURISA Tablets
Published Date: 9/30/2026
Notice
Summary
The FDA has decided that ISTURISA (osilodrostat) 10 mg tablets were not taken off the market because of safety or effectiveness problems. This means generic drug makers can now apply to sell their own versions of ISTURISA, as long as they meet all the rules. Patients and pharmacies could see more affordable options soon, with no safety worries involved.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 0 costs, 1 mixed.
Generic makers may seek approval
The FDA determined that ISTURISA (osilodrostat) 10 mg tablets were not withdrawn for reasons of safety or effectiveness, so abbreviated new drug applications (ANDAs) that refer to ISTURISA (NDA 212801) may be approved if they meet all other legal and regulatory requirements. This determination follows a citizen petition dated April 24, 2026, and references the original approval of ISTURISA on March 6, 2020.
Product listed as discontinued for non-safety reasons
FDA will continue to list ISTURISA (osilodrostat) 10 mg in the Orange Book 'Discontinued Drug Product List,' which denotes products discontinued from marketing for reasons other than safety or effectiveness. The Agency reviewed records and postmarketing data and found no information indicating withdrawal for safety or effectiveness.
Possible labeling updates for ANDA applicants
The FDA said that if it determines ISTURISA's labeling should be revised to meet current standards, the Agency will advise ANDA applicants to submit such updated labeling when seeking approval for a generic version. ANDA approval remains contingent on meeting all other legal and regulatory requirements.
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