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FDA Approves Otsuka and Lundbeck's Abilify for Schizophrenia and Bipolar I Disorder


First once-every-two-months long-acting injectable offers sustained therapeutic concentrations for patients.

Otsuka America Pharmaceutical, Inc. and Lundbeck announced the FDA's approval of Abilify (aripiprazole), the first once-every-two-months long-acting injectable (LAI) for the treatment of schizophrenia or maintenance monotherapy treatment of bipolar I disorder in adults. The extended-release injectable suspension delivers sustained therapeutic concentrations with one dose, providing continuous delivery of medication to help maintain therapeutic plasma concentrations in patients living with schizophrenia and bipolar I disorder.

U.S. Food and Drug Administration FDA approved vector stamp | ©Calin | Adobe Stock

The approval marks a significant milestone in offering a new treatment option for those living with these mental health conditions.

Reference: FDA Approves Otsuka and Lundbeck’s ABILIFY ASIMTUFII® (aripiprazole), the First Once-Every-Two-Months Long-acting Injectable (LAI) for the Treatment of Schizophrenia or Maintenance Monotherapy Treatment of Bipolar I Disorder in Adults | PRINCETON, N.J. & DEERFIELD, April 27, 2023 / Business Wire

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