FDA approves Abilify for teens

TOKYO and PRINCETON, N.J. The Food and Drug Administration has approved the Otsuka Pharmaceuticals and Bristol-Myers Squibb drug application for Abilify for the acute treatment of manic and mixed episodes associated with bipolar I disorder, with or without psychotic features in pediatric patients aged 10 to 17.

The approval is based on the results of a four-week study that compared Abilify to a placebo in treating pediatric patients with bipolar disorder I. Otsuka Pharmaceuticals sponsored the study.

“We are pleased that the FDA has approved Abilify to treat pediatric patients aged 10 to 17 years suffering from Bipolar I Disorder,” said Taro Iwamoto, Ph.D., chief executive officer, president and chief operating officer, Otsuka Pharmaceutical development and c commercialization. “The approval of this new indication for ABILIFY provides clinicians with expanded treatment options that can help address the therapeutic needs of this population.”