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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: sodium stibogluconate
Date Designated: 10/28/2009
Orphan Designation: Treatment of cutaneous leishmaniasis
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 09/11/2023
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Surgeon General of the US Army
US Army Medical Research & Materiel Command
1430 Veterans Drive
Ft. Detrick, Maryland 21702
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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