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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: AAV8/TTR-hFVa - adeno associated virus, serotype 8 with a mouse transthyretin promoter/enhancer and encoded transgene for human clotting Factor Va
Date Designated: 10/27/2021
Orphan Designation: treatment of hemophilia A and hemophilia B with or without inhibitors
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
GeneVentiv Therapeutics, Inc.
312 Buncombe Street
Raleigh, North Carolina 27609
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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