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Double Bonus: Novartis Antimalarial Coartem Receives Both FDA Approval and First Priority Review Voucher in History

Exactly one week ago, the FDA gave the nod to Novartis’ antimalarial drug Coartem, simultaneously granting it the first Priority Review Voucher (PRV) in FDA history. As reported in this blog several times before, the PRV program was enacted by an amendment to FDA law in September of 2007. The amendment gives FDA the authority to award a PRV to the sponsor (company/entity) of a newly-approved neglected disease product application. The fully-tradable voucher can then be used to obtain a priority (6 month) review for another product application of its choosing†. Read More…