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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: artesunate
Date Designated: 02/04/2025
Orphan Designation: treatment of vulvar intraepithelial neoplasia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Frantz Viral Therapeutics, LLC
7740 Metric Drive
Mentor, Ohio 44060
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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