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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
Date:11/15/2007

- Otsuka-sponsored Study Evaluated Use of ABILIFY in Patients Ages 10 to 17

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TOKYO, Japan and PRINCETON, N.J., Nov. 15 /PRNewswire-FirstCall/ -- 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 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 product is assigned if a product, if approved, could represent an improvement compared to marketed products, including non-drug products/therapies in the treatment, diagnosis or prevention of a disease. The FDA goal for reviewing a drug with Priority Review is six months.

This sNDA is based on data from a multicenter, randomized, double-blind, placebo-controlled study of two fixed oral doses of ABILIFY (10 mg/day or 30 mg/day). The efficacy and safety of ABILIFY were assessed in 296 ethnically diverse pediatric patients (ages 10 to 17) with Bipolar I Disorder over a 30- week treatment timeframe, which consisted of a four-week double-blind acute phase, followed by a 26-week double-blind continuation phase. This trial was sponsored by Otsuka Pharmaceutical Co., Ltd. and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc. (Princeton, NJ) and was conducted at 54 centers in the U.S.

About ABILIFY(R) (aripiprazole)

The first and only available dopamine partial agonist, ABILIFY is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults. ABILIFY is also indicated for the treatment of schizophrenia in adults and adolescents (13 to 17 years old). ABILIFY(R) (aripiprazole)
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SOURCE Otsuka Pharmaceutical Co., Ltd.; Bristol-Myers SquibbCompany
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