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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 (AAV) vector-based gene therapy
Date Designated: 10/16/2023
Orphan Designation: Treatment of Amyotrophic Lateral Sclerosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Rejukon Biopharm Inc.
Building 22, Baijiatong, Lane 388, Shengrong
Road, Pudong New Area
Shanghai, China
China

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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