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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: cholic acid
Trade Name: Cholbam
Date Designated: 07/18/2003
Orphan Designation: Treatment of inborn errors of cholesterol and bile acid synthesis and metabolism
Orphan Designation Status: Designated/Approved
Mirum Pharmaceuticals, Inc.
989 E Hillsdale Blvd., Suite 300
Foster City, California 94404
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: cholic acid
Trade Name: Cholbam
Marketing Approval Date: 03/17/2015
Approved Labeled Indication: Treatment of bile acid synthesis disorders due to single enzyme defects
Exclusivity End Date: 03/17/2022 
Exclusivity Protected Indication* :  Treatment of bile acid synthesis disorders due to single enzyme defects
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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