Novartis Coartem NDA May Lead to First Priority Review Voucher

Malaria drug receives "priority" status from FDA, which should mean Novartis receives a voucher for priority designation on another product under new incentive program for tropical disease research. December application deadline also sets a deadline for FDA to defi ne key elements of how PRVs will work.

By Michael McCaughan

Novartis' pending application for approval of the malaria treatment Coartem (artemether/lumefantrine) puts the company in line to be among the...

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