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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Recombinant adeno-associated virus serotype 8 (rAAV2/8) vector expressing bioengineered B domain deleted liver-codon-optimized human factor VIII
Date Designated: 01/27/2020
Orphan Designation: Treatment of Hemophilia A
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
ASC Therapeutics, Inc.
521 Cottonwood Dr.
Milpitas, California 95035
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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