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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: uridine triacetate
Date Designated: 03/21/2025
Orphan Designation: treatment of CAD (carbamoyl-phosphate synthetase 2, aspartate transcarbamoylase, and dihydroorotase) deficiency (DEE50)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
BTG International Inc
300 Four Falls Corporate Center
300 Conshohocken State Road, Suite 300
West Conshohocken, Pennsylvania 19428-3820
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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