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# Panel to Discuss Ocaliva Confirmatory Data
- URL: https://www.fdaweb.com/panel-to-discuss-ocaliva-confirmatory-data/
- Published: 2024-08-12T12:00:00.000Z
- Updated: 2026-09-14T14:38:00.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157547

*Federal Register* notice: FDA is announcing a 9/13 Gastrointestinal Drugs Advisory Committee meeting to discuss an Intercept Pharmaceuticals supplemental NDA for Ocaliva (obeticholic acid) that was filed to fulfill its 2016 accelerated approval postmarketing requirements. The submission includes data describing and verifying clinical benefit for treating adult patients with primary biliary cholangitis without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-08-12/pdf/2024-17926.pdf?ref=fdaweb.com).