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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 virus serotype 9 vector containing human Iduronate-2-sulfatase transgene
Date Designated: 07/16/2015
Orphan Designation: Treatment of mucopolysaccharidosis type II (Hunter syndrome).
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Esteve Pharmaceuticals, S.A.
109 Passeig de la Zona Franca
4th Floor
Barcelona, Catalunya
Spain

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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