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Otsuka Pharmaceutical Co., Ltd. and Lundbeck Inc. (LUN.CO) Initiate the Regulatory Process for Aripiprazole (Once-Monthly) Depot Formulation in Europe


12/27/2012 9:40:22 AM

TOKYO & COPENHAGEN, Denmark--(BUSINESS WIRE)--Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) today announced the European Medicines Agency's (EMA) acceptance of the submission of a marketing authorisation application (MAA) for the approval of aripiprazole depot formulation. The application of aripiprazole depot formulation is for the maintenance treatment of adult patients with schizophrenia. "Our efforts to bring the aripiprazole depot formulation to market demonstrate our long-term commitment to discover, develop and champion treatments for the most challenging psychiatric diseases," said William H. Carson, M.D., President and CEO, Otsuka Pharmaceutical Development & Commercialization, Inc. "If approved, more patients with schizophrenia will have access to the efficacy and safety profile of aripiprazole in a once-monthly formulation."

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