Volume 87 Issue 16 | p. 20 | Concentrates
Issue Date: April 20, 2009

Novartis Wins First U.S. Review Voucher

Department: Business
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Researchers strategize in a lab at the Novartis Institute for Tropical Diseases, in Singapore.
Credit: Novartis
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Researchers strategize in a lab at the Novartis Institute for Tropical Diseases, in Singapore.
Credit: Novartis

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).

 
Chemical & Engineering News
ISSN 0009-2347
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