FAQs: OCALIVA US Market Withdrawal
On September 11, 2025, Intercept Pharmaceuticals announced the voluntary withdrawal of OCALIVA® (obeticholic acid) from the US market. Following a transition period for patients to consult with their healthcare providers about other treatment options, OCALIVA was officially withdrawn from the US commercial market on November 14, 2025.
The withdrawal of OCALIVA from the US market was not due to a manufacturing defect or contamination issues involving existing product supply.
The information found here addresses a range of questions related to this market withdrawal. For questions not addressed here, contact info@interceptpharma.com.
As of November 14, 2025, OCALIVA has been withdrawn from the US commercial market.
This was not a medication recall. More details about the decision to withdraw OCALIVA from the US market can be found here.
Other therapies are FDA approved for the treatment of PBC. Individuals diagnosed with PBC should consult their healthcare providers about appropriate treatment options.
Intercept patient support services (Interconnect) will continue to be available until December 31, 2025. The phone number for Interconnect is 1-844-622-4278.
Healthcare professionals can contact Medical Information at 1-844-782-4278 or medinfo@interceptpharma.com. To submit a request for medical information, visit www.interceptmedinfo.com.
Patients should consult their healthcare providers about any treatment decisions. Additionally, patients can contact their specialty pharmacies for assistance in disposing of unwanted remaining medicine.
Yes. Claims will be accepted through December 31, 2025, for services or purchases made on or before November 14, 2025. Claims submitted after this date will not be processed.
Patients should immediately report any adverse event to their healthcare provider and both patients and healthcare providers can submit adverse event reports via email to drugsafety@interceptpharma.com or by calling 1-844-782-4278. For product complaints, call 1-844-782-4278 or complete this form and email it to productcomplaint@interceptpharma.com.
An EAP is not available at this time.
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Exploring Racial Differences and Disparities in PBC Care
Intercept Pharmaceuticals, Inc., a wholly owned biopharmaceutical subsidiary of Alfasigma S.p.A., has voluntarily withdrawn OCALIVA® (obeticholic acid) from the market for the treatment of primary biliary cholangitis (PBC), effective November 14.
Patients should talk to their healthcare professionals and may also contact Intercept's patient support services (Interconnect at 1-844-622-4278) through December 31, 2025.
Healthcare professionals can contact Medical Information at medinfo@interceptpharma.com or 1-844-782-4278. Additionally, patients or healthcare professionals may request Full Prescribing Information or the OCALIVA Medication Guide by contacting medinfo@interceptpharma.com.
For all other inquiries please contact: info@interceptpharma.com