Malaria drug candidate faces FDA panel
Executive Summary
Novartis' malaria candidate Coartem (artemether/lumefantrine) will be assessed by the Anti-Infective Drugs Advisory Committee Dec. 3 for the treatment of acute, uncomplicated malaria infection due to Plasmodium falciparum or mixed infections including P. falciparum. The NDA is among the first to obtain a priority review voucher from FDA (1"The Pink Sheet," Sept. 22, 2008, p. 26)