Intercept Pharmaceuticals received FDA approval of its first orphan drug product obeticholic acid, marketed as Ocaliva. Ocaliva was granted accelerated approval for the 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. This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP).   Intercept began working wi...