November 19, 2009
FDA Approval Letter to Bristol-Myers Squibb for the Pediatric Use of Abilify to Treat Irritability Associated With Autism
The U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application for Abilify (aripiprazole) to treat irritability associated with autism in
children aged six to 17. The approval was based on the results of two eight-week, randomized, double-blind placebo-controlled studies which compared the
effectiveness of Abilify in reducing irritability and aggression to a placebo.

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