Issue Date: April 20, 2009
Novartis Wins First U.S. Review Voucher
Novartis has received FDA approval for Coartem, the first artemisinin-based combination treatment for malaria to be approved in the U.S. In conjunction with the approval, Novartis also wins the first priority review voucher (PRV), a coupon good for expediting the review of any other New Drug Application. PRVs are only awarded with the approval of novel drugs for neglected diseases and can be sold to another firm. FDA introduced the vouchers in 2007 to entice companies to devote research dollars to diseases that primarily affect developing countries (C&EN, Jan. 19, page 38).
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