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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: sepiapterin
Date Designated: 02/19/2020
Orphan Designation: Treatment of primary tetrahydrobiopterin deficiency
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
PTC Therapeutics, Inc. (PTC)
500 Warren Corporate Center Drive
Warren, New Jersey 07059
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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