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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
Trade Name:
Date Designated: 03/28/2006
Orphan Designation: Immediate treatment of malaria
Orphan Designation Status: Designated/Approved
Amivas Inc.
100 Tuscanney Drive, Suite B2
Frederick, Maryland 21702
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: artesunate
Trade Name:
Marketing Approval Date: 05/26/2020
Approved Labeled Indication: Artesunate for Injection is indicated for the initial treatment of severe malaria in adult and pediatric patients. Treatment of severe malaria with Artesunate for Injection should always be followed by a complete treatment course of an appropriate oral antimalarial regimen.
Exclusivity End Date: 05/26/2027 
Exclusivity Protected Indication* :  For the initial treatment of severe malaria in adult and pediatric patients to always be followed by a complete treatment course of an appropriate oral antimalarial regimen.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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