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# FDA Continues to Review Ocaliva sNDA
- URL: https://www.fdaweb.com/fda-continues-to-review-ocaliva-snda/
- Published: 2024-10-17T12:00:00.000Z
- Updated: 2026-09-14T14:44:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158001

FDA has informed Intercept Pharmaceuticals that the agency is continuing to review the company’s sNDA for full approval of Ocaliva (obeticholic acid, OCA) to treat indicated patients with primary biliary cholangitis. A company [statement](https://www.interceptpharma.com/about-us/news/?id=2964897&ref=fdaweb.com) said FDA indicated that the original PDUFA action date of 10/15 has been delayed and no new anticipated action date was announced.

The agency communication followed a Gastrointestinal Drugs Advisory Committee 9/13 meeting that voted 10-1 that the drug does not have a benefit/risk profile that would support its full approval.