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Keeping Track: US FDA Shoots Down Lilly's Baricitinib, Approves Neurocrine's Ingrezza

 
• By Bridget Silverman

The latest drug development news and highlights from our FDA Performance Tracker.

Keeping Track Feature image

Novel agents had a mixed week at FDA. The Center for Drug Evaluation and Research (CDER) approved one new molecular entity, Neurocrine Biosciences Inc.'s Ingrezza (valbenazine), but issued a complete response letter for another, Eli Lilly & Co. and Incyte Corp.'s baricitinib.

The Ingrezza approval continues the dominance of nervous system therapeutics among the 2017 novel approvals class. Ingrezza, a treatment for tardive dyskinesia, is CDER's fourteenth novel approval this year and the fifth new drug to treat nervous system disorders

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