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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: 2',3',5'-tri-o-acetyluridine
Date Designated: 01/13/2003
Orphan Designation: Treatment of mitochondrial disease
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Repligen Corporation
41 Seyon Street
Building 1, Suite 100
Waltham, Massachusetts 02453
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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