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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: an adeno-associated viral vector containing a codon-optimised human factor IX gene (AAV5-hFIXco)
Date Designated: 12/22/2011
Orphan Designation: Treatment of hemophilia B
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
uniQure, B.V.
Meiberdreef 61
1100 DA
Amsterdam
Netherlands

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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