Otsuka Pharmaceutical Co, Ltd., and Bristol-Myers Squibb Company (NYSE: BMY) 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? (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 Pharmaceutical Development & Commercialization, Inc. (Princeton, NJ) evaluating the use of ABILIFY in 302 ethnically diverse pediatric patients (ages 13-17) and was conducted at 101 centers in 13 countries.