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Article: FDA clears Abilify in pediatric bipolar patients.
- Article from:
- Pharma Marketletter
- Article date:
- March 10, 2008
CopyrightCOPYRIGHT 2008 Marketletter Publications Ltd. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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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, ...