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FDA Accepts For Review Otsuka Pharmaceutical Co., Ltd. And H. Lundbeck A/S (LUN.CO)’s Supplemental New Drug Application To Expand Abilify Maintena® (Aripiprazole) Labelling


4/30/2014 10:12:03 AM

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Valby, Denmark, 2014-04-30 15:01 CEST (GLOBE NEWSWIRE) -- Valby, Denmark and Princeton, New Jersey, USA, 30 April 2014 - H. Lundbeck A/S (Lundbeck) and Otsuka America Pharmaceutical, Inc. (OAPI) today announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the proposed expanded labeling of Abilify Maintena (aripiprazole) for extended-release injectable suspension to support broader use of the drug for treatment of patients in the acute phase of schizophrenia. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of 7 December 2014 to complete its review.

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