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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Adeno-associated virus (AAV)-based vector with an engineered capsid serotype SNY001 harboring human phenylalanine hydroxylase (hPAH) cDNA
Date Designated: 09/08/2023
Orphan Designation: Treatment of phenylketonuria (PKU)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sanofi US Services, Inc.
55 Corporate Drive
Bridgewater, New Jersey 08807
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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