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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 viruses 8 (AAV8)-based gene therapy vector that expresses B domain-deleted human factor VIII under the control of human liver-specific promoters
Date Designated: 12/19/2023
Orphan Designation: Treatment of Hemophilia A
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Gritgen Therapeutics Co., Ltd.
Unit E499, 5/F, Lecheng Plaza, Block II, Biomedical Industrial Park,
No. 218 Sangtian Street, Suzhou Industrial Park
Suzhou, Jiangsu Province
China

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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