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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Autologous human regulatory T cells transduced with a retroviral vector encoding an FVIII C2 T cell receptor (TCR), which specifically binds FVIII C2 2213-2227 epitope in the context with HLA DRB1*01:01
Date Designated: 09/26/2023
Orphan Designation: Treatment of hemophilia A with inhibitors
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
TeraImmune, Inc.
20400 Century Blvd
STE 125
Germantown, Maryland 20874
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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