# 2025-20767: FDA Approves Withdrawal of Obeticholic Acid Drug Applications from Market

2025-20767, Intercept Pharmaceuticals, Inc., et al.; Withdrawal of Approval of New Drug Application for OCALIVA (Obeticholic Acid) Tablets, 5 Milligrams and 10 Milligrams, and Three Abbreviated New Drug Applications for Obeticholic Acid Tablets, 5 Milligrams and 10 Milligrams, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-11-24, effective 2025-11-24 (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-20767
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-20767
- Title: Intercept Pharmaceuticals, Inc., et al.; Withdrawal of Approval of New Drug Application for OCALIVA (Obeticholic Acid) Tablets, 5 Milligrams and 10 Milligrams, and Three Abbreviated New Drug Applications for Obeticholic Acid Tablets, 5 Milligrams and 10 Milligrams
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 52976
- Published: 2025-11-24
- Effective: 2025-11-24
- Comments close: not stated
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Approves Withdrawal of Obeticholic Acid Drug Applications from Market

## 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.

## Abstract

The Food and Drug Administration (FDA) is withdrawing approval of the new drug application (NDA) for OCALIVA (obeticholic acid) tablets, 5 milligrams (mg) and 10 mg, held by Intercept Pharmaceuticals, Inc., 305 Madison Ave., Morristown, NJ 07960 (Intercept). In addition, FDA is withdrawing approval of three abbreviated new drug applications (ANDAs) for obeticholic acid tablets, 5 mg and 10 mg, from three separate ANDA holders. Intercept voluntarily requested withdrawal of its NDA, and Apotex, Inc., Lupin Limited, and MSN Laboratories Private Limited voluntarily requested withdrawal of their respective ANDAs, under Sec. 314.150(d) (21 CFR 314.150(d)). The expedited withdrawal procedures set forth in section 506(c)(3)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) have been waived.

## Effects PRIA read

- OCALIVA and Generics: Approvals Withdrawn: cost, high. 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 pha…
- Selling or Distributing These Tablets Becomes Illegal: cost, medium. 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 dist…
- Postmarketing Trial Found Safety Concerns: benefit, high. 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…

## Related documents

- [2026-16296](https://policyrisk.com/federal-register/2026-16296): Substances Generally Recognized as Safe, 2026-08-11
- [2026-14073](https://policyrisk.com/federal-register/2026-14073): Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign E…, 2026-07-13
- [2026-13047](https://policyrisk.com/federal-register/2026-13047): Establishment Registration and Product Listing for Tobacco Products, 2026-06-29
- [2025-04978](https://policyrisk.com/federal-register/2025-04978): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-03-25
- [2025-01840](https://policyrisk.com/federal-register/2025-01840): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-01-27
- [2026-20727](https://policyrisk.com/federal-register/2026-20727): Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorgani…, 2026-10-09

## Sources
- [2025-20767 on federalregister.gov](https://www.federalregister.gov/documents/2025/11/24/2025-20767/intercept-pharmaceuticals-inc-et-al-withdrawal-of-approval-of-new-drug-application-for-ocaliva)
- [2025-20767 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-11-24/pdf/2025-20767.pdf)

## Related
- [Previous: 2025-20766, Float Glass Products From China and Malaysia; Revised Schedule for the Subject…](https://policyrisk.com/federal-register/2025-20766)
- [Next: 2025-20768, Tobacco Products Scientific Advisory Committee; Notice of Meeting; Establishmen…](https://policyrisk.com/federal-register/2025-20768)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-20767 (as of 2026-06-08).