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Abilify Maintena FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (First approved February 28, 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 timeline 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

Further information

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