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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
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.
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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