The Medication(s) listed below have been approved by the Food & Drug Administration (FDA) as orphan products for treatment of this condition. There may be other products available
that are not considered orphan products.
obeticholic acid (Brand name: Ocaliva)
- Manufactured by
Intercept Pharmaceuticals, Inc
FDA-approved indication: Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
National Library of Medicine Drug Information Portal