FDA Approves Withdrawal of Obeticholic Acid Drug Applications from Market
Published Date: 11/24/2025
Notice
Summary
The FDA is officially pulling the approval for OCALIVA tablets (5 mg and 10 mg) and similar versions from three other companies, effective November 24, 2025. This affects patients, doctors, and pharmacies who use or sell these drugs, meaning they’ll need to find alternatives soon. The companies themselves asked for this change, so no surprise fees or penalties are involved.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
OCALIVA and Generics: Approvals Withdrawn
The FDA withdrew approval of the NDA for OCALIVA (obeticholic acid) tablets, 5 mg and 10 mg (NDA 207999), and three ANDAs for obeticholic acid tablets, 5 mg and 10 mg (ANDA 214862, ANDA 214980, ANDA 215017). Approval is withdrawn as of November 24, 2025, which affects patients, prescribers, and pharmacies connected to these products.
Postmarketing Trial Found Safety Concerns
FDA determined the postmarketing trial did not verify clinical benefit and found that OCALIVA-treated primary biliary cholangitis (PBC) patients with early-stage disease had an excess of liver transplants and deaths. FDA notified applicants and recommended voluntary withdrawal of approvals based on these findings.
Selling or Distributing These Tablets Becomes Illegal
After November 24, 2025, distributing OCALIVA or the listed obeticholic acid tablets into interstate commerce without an approved application is illegal and subject to regulatory action under sections 505(a) and 301(d) of the FD&C Act. Pharmacies, wholesalers, and other distributors should not distribute these products after that date.
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