US FDA accepts for review Otsuka and Lundbeck's sNDA filing for labeling update of Rexulti (brexpiprazole) for maintenance treatment of schizophrenia

8 February 2016 - Under the Prescription Drug User Fee Act (PDUFA), the PDUFA date is 23 September 2016.

For more details, go to: https://www.lundbeck.com/global

Michael Wonder

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Michael Wonder

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Medicine , US , Submission