NDAORALTABLETPriority Review
Approved
Apr 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Mechanism of Action
Tablets, a fixed dose combination of artemether and lumefantrine in the ratio of 1:6, is an antimalarial agent [see Microbiology (12.4)] .
Pharmacologic Class:
Antimalarial
Clinical Trials (3)
A Community Setting Study of Malaria After Systematic Treatment of Symptomatic Carriers of P. Falciparum With COA566 (Coartem®)
Started Nov 2010
14,075 enrolled
Malaria
Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks
Started Jun 2008
413 enrolled
Malaria
Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria
Started Jun 2006
1,395 enrolled
Malaria, Falciparum