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MHRA issues Medicine Defect Information about Aripiprazole
The regulatory body has issued guidance based on a complaint that stated a precipitate formed in Aripiprazole 1mg/ml oral solution.
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Aripiprazole
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Results of clinical phase III study of once-monthly aripiprazole IM depot formulation for the treatment of schizophrenia presented at APA
7 May 2012 | By H. Lundbeck A/S
H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced results from a clinical phase III clinical trial evaluating the efficacy, safety and tolerability of once-monthly aripiprazole intramuscular (IM) depot formulation for the maintenance treatment of adults with schizophrenia. Trial results were presented in four poster presentations at…
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NDA for aripiprazole depot formulation for maintenance treatment of adult patients with schizophrenia accepted
22 November 2011 | By H. Lundbeck A/S (Lundbeck)
H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced today that the US Food and Drug Administration (FDA) has determined that a new drug application (NDA) for Otsuka's investigational once-monthly aripiprazole depot formulation for the indication of maintenance treatment of schizophrenia in adults is sufficiently complete to permit…
