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Drug news

Lundbeck/Otsuka re-file Abilify Depot with the FDA as a treatment for Schizophrenia

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Last updated:13th Sep 2012

Published:13th Sep 2012

Source: Pharmawand

Lundbeck and Otsuka Pharmaceutical Co., Ltd. announced that the FDA has accepted for review the resubmission of the New Drug Application (NDA) for aripiprazole depot formulation, a potential treatment for schizophrenia. FDA stated that this resubmission constituted a complete class 2 response to their action letter of July 26, 2012. The Prescription Drug User Fee Act (PDUFA) goal date is 28 February 2013. The NDA was resubmitted in response to a Complete Response Letter (CRL) Otsuka received from the FDA on 26 July 2012 which cited deficiencies from a recent inspection of a third party supplier

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