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Article: ABILIFY(R) (aripiprazole) Supplemental New Drug Application for the Treatment of Pediatric Patients with Bipolar I Disorder Accepted for Priority Review by the U.S. Food and Drug Administration.
- Article from:
- PR Newswire
- Article date:
- November 15, 2007
CopyrightCOPYRIGHT 2007 PR Newswire Association LLC. 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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- Otsuka-sponsored Study Evaluated Use of ABILIFY in Patients Ages 10 to 17 -
TOKYO, Japan and PRINCETON, N.J., Nov. 15 /PRNewswire-FirstCall/ -- Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted a Priority Review to the supplemental New Drug Application (sNDA) of the atypical antipsychotic ABILIFY(R) (aripiprazole) for the treatment of pediatric patients (10 to 17 years old) diagnosed with Bipolar I Disorder, manic or mixed episode with or without psychotic features.
Priority Review status for an application or supplement for a drug ...