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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 methioninase
Date Designated: 08/28/2023
Orphan Designation: Treatment of small cell lung cancer
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Guangzhou Sinogen Pharmaceutical Co., Ltd.
No.11 Kai Yuan Ave., Huangpu Dist.
Building C5, Room 101
Guangzhou, Guangzhou 510530
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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