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US FDA Blows Past Novel Approvals Record On Way To Unprecedented Year For New Drugs

 
• By Bridget Silverman

Roche’s Xofluza brings novel approval count for CDER to 47, topping 2017's record – and FDA still has at least 14 novel agents under review with 2018 goal dates.

Female athletes running towards finish line on track field

With two months remaining in 2018, the US FDA’s drug center has already exceeded last year’s record approval count, with no signs of a slow-down on the horizon.

Shionogi & Co. Ltd. and Roche’s Xofluza became the forty-seventh novel agent cleared this year by the Center for Drug Evaluation and Research with its Oct. 24 approval for treatment of uncomplicated influenza

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