Intercept Announces FDA Acceptance of Supplemental New Drug Application for Ocaliva® (obeticholic acid) for the Treatment of PBC
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2024.
- The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 15, 2024.
- In this communication, the agency informed Intercept that they are planning to hold an Advisory Committee meeting to discuss the application.
- The precedent-setting sNDA for Ocaliva is intended to satisfy the post-marketing requirements to confirm a clinical benefit in patients with PBC.
- Intercept and Alfasigma remain committed to supporting people living with PBC and look forward to advancing discussions with the agency.