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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 Human Adeno-Associated Virus Serotype 2 Containing Human Mitochondrial ND4 gene (rAAV2-ND4)
Date Designated: 09/22/2020
Orphan Designation: Treatment of Leber's Hereditary Optic Neuropathy
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Neurophth Therapeutics, Inc.
200 Continental Drive
Suite 401, Room 411
New Castle, Delaware 19713
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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