Neurocrine Biosciences (NBIX) Says FDA Panel to Review INGREZZA on 02/16/17, PDUFA set for 04/11/17

November 29, 2016 4:16 PM EST

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Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced that the Psychopharmacologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data included in the New Drug Application (NDA) of INGREZZATM (valbenazine) for the treatment of tardive dyskinesia on February 16, 2017. The FDA has granted Priority Review status to the INGREZZA NDA with a Prescription Drug User Fee Act (PDUFA) target action date of April 11, 2017.

The NDA for INGREZZA includes the results from the Kinect 2 and Kinect 3 clinical trials which evaluated over 330 tardive dyskinesia patients. Data from these studies along with the results from another 18 clinical trials, extensive preclinical testing and drug manufacturing data were included in the NDA submission.



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