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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: artemether/lumefantrine
Trade Name: Coartem
Date Designated: 08/31/2007
Orphan Designation: For the treatment of infections due to Plasmodium falciparum or mixed infections including P. falciparum.
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals
Bldg 405/4051
One Health Plaza
East Hanover, New Jersey 07936
United States

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

Marketing approved:

1 Generic Name: artemether/lumefantrine
Trade Name: Coartem
Marketing Approval Date: 04/07/2009
Approved Labeled Indication: Treatment of malaria in patients of 5 kg bodyweight or above with acute, uncomplicated malaria due to Plasmodium falciparum or mixed infections including P. falciparum
Exclusivity End Date: 04/07/2016 
Exclusivity Protected Indication* :  

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