April 09, 2009
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New malaria treatment approved

The FDA has approved oral artemether and lumefantrine tablets (Coartem, Novartis) for the treatment of acute, uncomplicated malaria.

The medication is indicated for adults and children who weigh at least 11 kg and is not intended for malaria prevention, or as a severe malaria treatment.

“It is encouraging to have new treatment available, particularly for children,” Murray M. Lumpkin, MD, deputy commissioner for the International and Special Programs at the FDA said in a press release.

Artemether, derived from the leaves of the Artemisia annua plant and one of the tablet’s active ingredients, is the first artemesinin-class drug approved in the United States.

The approval comes as concerns about resistance to other malaria drugs grow. Clinical trials have demonstrated the new tablet is effective in regions where chloroquine resistance has been reported.