FDA accepts filing of NDA for brexpiprazole for Depression and Schizophrenia and provides PDUFA date - Otsuka + Lundbeck
The FDA has determined that the New Drug Application (NDA) for brexpiprazole from Otsuka and Lundbeck for monotherapy in adult patients with schizophrenia and for adjunctive treatment of major depressive disorder (MDD) in adult patients is sufficiently complete to allow for a substantive review and the NDA is considered filed as of 9 September 2014 (60 days after submission). The PDUFA date is July 11, 2015.
The drug is being developed by Otsuka in collaboration with Lundbeck, and is considered to be a successor of the top-selling antipsychotic agent Abilify (aripiprazole) whose patent expires in April 2015.
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