Posted from: Friday, October 31, 2014 - 12:24 PM - Present

FDA Approves New Dosage Form of Abilify Maintena

September 29, 2014 – The US Food and Drug Administration (FDA) approved Abilify Maintena (aripiprazole) as prefilled syringes for extended-release injectable suspension manufactured by Ostuka and Lundbeck.  Abilify Maintena is a long-acting, once monthly treatment for schizophrenia administered via intramuscular injection.  Currently the Abilify Maintena Kit includes a vial of sterile water that has to be pulled into a syringe and injected into a vial of dried aripiprazole and mixed that must then be drawn into another syringe for injection by a healthcare professional.  The new dosage form is packaged with the active ingredient and the sterile water in separate sections that get mixed without having to be drawn into different syringes.  The prefilled syringes of Abilify Maintena are anticipated to be launched in January, 2015 in 300 mg and 400 mg strengths.


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Last Updated Monday, October 21, 2019 - 10:32 AM.