Otsuka and Lundbeck announced that the Food and Drug Administration (FDA)  has accepted for review the supplemental New Drug Application (sNDA) for the expanded labeling of Abilify Maintena (aripiprazole extended-release) for the maintenance treatment of bipolar I disorder in adults. 

The sNDA is seeking to include maintenance treatment for bipolar I disorder. The FDA has determined that the application is sufficiently complete for a substantive review. 

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Abilify Maintena, an atypical antipsychotic, is indicated to treat schizophrenia and Tourette’s disorder. Each vial or pre-filled syringe contains 300mg or 400mg aripiprazole extended-release injectable suspension for intramuscular (IM) injection after reconstitution. The efficacy of aripiprazole may be mediated through a combination of partial agonist activity at D2 and 5-HT1A receptors and antagonist activity at 5-HT2A receptors.

The FDA has set a target Prescription Drug User Fee Act (PDUFA) date of July 28, 2017. 

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