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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
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 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
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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