FAQ: OCALIVA US Market Withdrawal

FDA has agreed to a transitional period during which OCALIVA will remain available to allow time for patients to be transitioned to an alternative therapy. After this transition period, which will conclude on November 14, 2025, OCALIVA will no longer be commercially available in the US.

Patients should contact their healthcare providers as soon as possible to discuss treatment options. Patients should not stop any medication without speaking to their healthcare providers and should continue regular blood tests and follow-up visits as scheduled.

No. Patients should not stop taking OCALIVA without first consulting their healthcare providers, who will guide next steps, including a transition to other treatment options for managing primary biliary cholangitis (PBC).

No, this is not a medicine recall. The withdrawal of OCALIVA from the US market is voluntary and was made at FDA’s request. It is not due to a manufacturing defect, contamination, or any other issue requiring an immediate recall.

Patients should talk with their healthcare provider before making any treatment decisions.

Other therapies are FDA approved for the treatment of PBC in the US. Healthcare providers are in the best position to determine the most appropriate treatments for their patients.

Patients should work with their healthcare providers and insurers to go through a coverage approval process (e.g., prior authorization), and to evaluate formulary and coverage.

FDA did not agree to the establishment of an EAP for OCALIVA.

Intercept Patient Support Services (Interconnect) will continue to be available for 30 days following the official market withdrawal date of Nov. 14, 2025. The phone number for Interconnect is 1-844-622-4278.

Healthcare professionals who have questions about OCALIVA can contact Intercept Medical Information at medinfo@interceptpharma.com or call 1-844-782-4278. Patients should speak with their healthcare professionals and also may contact Intercept’s Patient Support Services (Interconnect) at 1-844-622-4278.

We understand how important treatment options are for patients with PBC, a rare and progressive disease. The Company remains committed to the PBC and liver disease community and to continuing our work in finding solutions to unmet patient needs.