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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: obeticholic acid
Trade Name: OCALIVA
Date Designated: 04/09/2008
Orphan Designation: Treatment of primary biliary cirrhosis
Orphan Designation Status: Designated/Approved/Designation Withdrawn or Revoked
Intercept Pharmaceuticals, Inc.
4760 Eastgate Mall
San Diego, California 92122
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
1 Generic Name: obeticholic acid
Trade Name: OCALIVA
Marketing Approval Date: 05/27/2016
Approved Labeled 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
Exclusivity End Date: 05/27/2023 
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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