Posted by Michael Wonder on 05 Aug 2015
U.S. FDA accepts Otsuka and Lundbeck's filing for review of brexpiprazole for the treatment of schizophrenia and as adjunctive therapy for the treatment of major depression
Otsuka Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Otsuka Holdings Co. Ltd., and H. Lundbeck A/S today announced that the U.S. Food and Drug Administration (FDA) has determined that the New Drug Application (NDA) for brexpiprazole 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.
For more details, go to: http://www.otsuka.com/en/hd_release/release/pdf.php?news=1007
