FDA issues complete response for once-monthly aripiprazole

Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) and partner H. Lundbeck A/S (CSE:LUN) said FDA issued a complete response letter for an NDA for a once-monthly depot formulation of aripiprazole for the maintenance treatment of schizophrenia. The pharma said the only issue FDA cited in the letter was deficiencies from a recent inspection of a third-party supplier of sterile water. Otsuka said it plans to discuss next steps with the agency. Last November, Otsuka and Lundbeck partnered to co-develop and co-commercialize up to five psychiatric therapies, including once-monthly aripiprazole (see BioCentury, Dec. 5, 2011). ...