FDA Law Blog -- Earlier today, FDA announced the approval of Novartis’ combination drug product COARTEM (artemether; lumefantrine) for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilograms. Accompanying the approval is the first Priority Review Voucher (“PRV”) granted by FDA. There has been significant debate about the value of a PRV, and any decision by Novartis to sell the PRV will be closely watched.
