NDA for aripiprazole depot formulation for maintenance treatment of adult patients with schizophrenia accepted
H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka)…
22 November 2011 | By H. Lundbeck A/S (Lundbeck)
H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced today that the US Food and Drug Administration (FDA) 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…