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Article: ABILIFY(R) (aripiprazole) Supplemental New Drug Application for Pediatric Patients With Schizophrenia Accepted for Priority Review by the U.S. Food and Drug Administration.
- Article from:
- PR Newswire
- Article date:
- June 5, 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 13-17 -
TOKYO and PRINCETON, N.J., JUNE 5 /PRNewswire/ -- Otsuka Pharmaceutical Co., Ltd., and Bristol-Myers Squibb Company announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority (six month review target) review the supplemental New Drug Application (sNDA) of the atypical antipsychotic ABILIFY(R) (aripiprazole) for the treatment of pediatric patients (13-17 years old) with schizophrenia. This sNDA is based on data from a six-week, double-blind, randomized, placebo-controlled study, sponsored by Otsuka Pharmaceutical Co., Ltd., and its U.S. subsidiary, Otsuka ...