FDA clears Abilify in pediatric bipolar patients

The US Food and Drug Administration has approved Japanese firm Otsuka Pharmaceutical and US drug major Bristol-Myers Squibb's supplemental New Drug Application for Abilify (aripiprazole) for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder, with or without psychotic features in pediatric patients aged10 to 17. The drug has been approved for the acute and maintenance treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults since September 2004 and March 2005, respectively.

"Pediatric bipolar illness is a serious condition," said Christoph Correll, medical director, Recognition and Prevention Program at the The Zucker Hillside Hospital and assistant professor of psychiatry and behavioral sciences at the Albert Einstein College of Medicine, Glen Oaks, New York. "The availability of an additional treatment option that can help guide decisions in managing Bipolar I Disorder in children and adolescents is welcome news," he noted.