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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  dihydroartemisinin and piperaquine
Date Designated:  01/08/2007
Orphan Designation:  Treatment of uncomplicated malaria caused by "Plasmodium falciparum," Plasmodium vivax," Plasmodium malariae," or "Plasmodium ovale."
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Alfasigma S.p.A
223 Viale Sarca
Milano, Lombardia

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.