FDA Awards First-Ever Priority Review Voucher To Novartis For Coartem Approval
This article was originally published in The Pink Sheet Daily
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Sponsor preferred a tropical disease voucher because it could be redeemed for a supplemental application, but the FDA awarded a voucher under the medical countermeasures program, which prohibits redemption for supplements; agency says it takes a case-by-case approach to deciding whether tropical disease and rare pediatric disease vouchers can be redeemed for supplements.
Approval of the leishmaniasis treatment by its December user fee date would give the Canadian sponsor a voucher for a priority review, which it is likely to sell to another company.
Arthritis Advisory Committee votes against approval of Novartis' biologic for treatment of gout attacks, citing the need for more data on long-term safety and retreatment, along with a narrower indication.