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Abilify Maintena FDA Approval History

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

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

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

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Development timeline for Abilify Maintena

DateArticle
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

See also

Abilify Maintena (aripiprazole) Consumer information

Further information

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