Bristol-Myers Squibb Co. and Otsuka Pharmaceutical Co., Ltd. said that FDA has approved the supplemental New Drug Application or sNDA for Abilify for the treatment of irritability associated with autistic disorder in pediatric patients of ages 6 to 17 years. The approval of Abilify for the treatment of irritation in patients with autistic disorder in pediatric patients is based on data from two eight-week, randomized, double-blind, placebo-controlled, multi-center, Phase III studies.

The FDA has approved a supplemental NDA (new drug application) submitted by Otsuka Pharmaceutical and Bristol-Myers Squibb for Abilify (aripiprazole) to treat manic and mixed episodes related to bipolar I disorder in children between 10 and 17 years of age. The drug already has approval for the treatment of manic and mixed episodes related to Bipolar I Disorder with or without psychotic features in adults.