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U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
Date:2/29/2008

(7% vs 3%), restlessness

(6% vs 3%), and extrapyramidal disorder (5% vs 2%)

-- Pediatric patients (10 to 17 years) with Bipolar I Disorder:

somnolence (23% vs 3%), extrapyramidal disorder (20% vs 3%), fatigue

(11% vs 4%), nausea (11% vs 4%), akathisia (10% vs 2%), blurred vision

(8% vs 0%), salivary hypersecretion (6% vs 0%), and dizziness

(5% vs 1%)

-- Adult patients with agitation associated with bipolar mania: nausea

(9% vs 3%)

Please see FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, for ABILIFY.

About Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb

Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb are collaborative partners in the development and commercialization of ABILIFY in the United States and major European countries.

ABILIFY was discovered by Otsuka Pharmaceutical Co., Ltd. Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: "Otsuka -- people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to the high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural environment. The Otsuka Pharmaceutical Group comprises 99 companies and employs approximately 31,000 people in 18 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned U.S. $7.2 billion in annual revenues in fiscal 2006.

Bristol-Myers Squibb is a global biopharmaceutical and related healthcare products company whose mission is to extend and enhance human life.
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SOURCE Otsuka Pharmaceutical Co., Ltd.
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