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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 2/9 expressing human GALT gene (AAV2/9-hGALT)
Date Designated: 09/28/2021
Orphan Designation: Treatment of galactosemia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Jaguar Gene Therapy, LLC
Two Conway Park
150 N. Field Drive, Suite 300
Lake Forest, Illinois 60045
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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