New Injection Site under FDA Review for Abilify Maintena

Otsuka and Lundbeck announced that the Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) for a proposed new injection site, the deltoid muscle of the arm for Abilify Maintena (aripiprazole) extended-release injectable suspension.

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Abilify Maintena, an atypical antipsychotic, is currently available as an intramuscular depot formulation of aripiprazole for the treatment of schizophrenia. It is a sterile lyophilized powder that, when reconstituted with sterile water for injection, forms an injectable suspension that can be administered monthly into the gluteal muscle. After an initial injection of Abilify Maintena along with an overlapping 14-day dosing of oral antipsychotic treatment, subsequent injections of Abilify Maintena provide medication coverage for 30 days at a time. Depot formulations enable concentrations of an active drug to remain at the therapeutic range for an extended period of time.

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