17 October 2024 - Intercept Pharmaceuticals today announced that the US FDA has informed the Company that it is continuing its review of the supplemental new drug application for full approval of Ocaliva (obeticholic acid) for the treatment of indicated patients with primary biliary cholangitis, and its action under the PDUFA, expected on 15 October 2024, has been delayed. 

The FDA did not provide a new anticipated action date.

Read Intercept Pharmaceuticals press release