FDAnews Drug Daily Bulletin

FDA Approves Two-Month Aristada Dose for Schizophrenia

June 12, 2017

Alkermes received FDA approval for a two-month dose of Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia.

Aristada is now approved in four doses and three dosing duration options (441 mg, 662 mg or 882 mg once monthly, 882 mg once every six weeks and 1064 mg once every two months) and can be initiated at any dose or interval.

This is an option to treat schizophrenia symptoms with only six injections per year. The new two-month dose is expected to be available in mid-June, according to the company. Aristada was originally approved by the FDA in October 2015.

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