Aripiprazole depot regulatory update

Otsuka and partner Lundbeck said FDA accepted for review a resubmitted NDA for a once-monthly depot formulation of aripiprazole for the maintenance treatment of schizophrenia. The agency designated the application as a class 2 resubmission, with a Feb. 28, 2013, PDUFA date. FDA issued a complete response letter for the NDA in July, citing deficiencies from a recent inspection of a third-party supplier of sterile water (see BioCentury, July 30). ...