Press Release: Intercept : Intercept Provides Regulatory Update Regarding sNDA for OCALIVA

MORRISTOWN, N.J., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a wholly owned subsidiary of Alfasigma S.p.A., today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it is continuing its review of the supplemental New Drug Application (sNDA) for full approval of OCALIVA® (obeticholic acid, OCA) for the treatment of indicated patients with primary biliary cholangitis (PBC), and its action under the Prescription Drug User Fee Act (PDUFA), expected on October 15, 2024, has been delayed. The FDA did not provide a new anticipated action date.