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Abilify Maintena Approval History

  • FDA approved: Yes (First approved February 28th, 2013)
  • Brand name: Abilify Maintena
  • Generic name: aripiprazole
  • Dosage form: for Extended-Release Injectable Suspension
  • Company: Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S
  • Treatment for: Schizophrenia, Bipolar Disorder

Abilify Maintena (aripiprazole) is an atypical antipsychotic indicated for the treatment of schizophrenia, and maintenance monotherapy treatment of bipolar I disorder.

Development History and FDA Approval Process for Abilify Maintena

Jul 28, 2017Approval Abilify Maintena (aripiprazole) for Extended-Release Injectable Suspension Approved by the U.S. FDA for Maintenance Monotherapy Treatment of Bipolar I Disorder
Dec  6, 2014Approval FDA Approves Labeling Update Of Abilify Maintena for Acutely Relapsed Adults With Schizophrenia
Sep 29, 2014Approval FDA Approves Dual-Chamber Syringe for Abilify Maintena (aripiprazole) for Schizophrenia
Mar  1, 2013Approval FDA Approves Once-Monthly Abilify Maintena (aripiprazole) for Extended-Release Injectable Suspension for the Treatment of Schizophrenia

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