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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: saRNA oligonucleotide designed to target and upregulate the expression of human utrophin gene (UTRN)
Date Designated: 08/21/2024
Orphan Designation: treatment of Duchenne muscular dystrophy and Becker muscular dystrophy
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Ractigen Therapeutics
Building 18, 888 Zhujiang Rd.
Rudong
Nantong, Jiangsu 226400
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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