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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: a genetically modified salmonella comprising of Diphtheria toxin A subunit
Date Designated: 02/21/2025
Orphan Designation: treatment of neuroblastoma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Shanghai Salvectors Biotechnology LTD.
Room 301, Block B, Building 1
800 Qingdai Road, Pudong New Area
Shanghai, Shanghai 201318
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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