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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: lentiviral vector containing the human MY07A gene
Date Designated: 05/17/2010
Orphan Designation: Treatment of retinitis pigmentosa associated with Usher syndrome 1B gene defect.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sanofi US Services Inc.
50 Binney Street
Cambridge, Massachusetts 02142
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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