New Drug Application for Otsuka Pharmaceutical Co., Ltd.'s Once-Monthly Aripiprazole Depot Formulation for Maintenance Treatment of Adult Patients with Schizophrenia Accepted for Review by the U.S. FDA

TOKYO & COPENHAGEN, Denmark--(BUSINESS WIRE)--Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S announced today that the U.S. Food and Drug Administration has determined that a new drug application (NDA) for Otsuka's investigational once-monthly aripiprazole depot formulation for the indication of maintenance treatment of schizophrenia in adults is sufficiently complete to permit a substantive review.