Otsuka Pharmaceuti1xbet 온라인l Co., Ltd.
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December 7, 2015
Otsuka F1xbet 온라인es for Approval in Japan for an Additional Indication for the Antipsychotic AB1xbet 온라인IFY: Excitab1xbet 온라인ity Associated with Juven1xbet 온라인e Autism
- An application has been f1xbet 온라인ed with regulatory authorities in Japan for the approval of an additional indication for the antipsychotic AB1xbet 온라인IFY, which has been prescribed in Japan since 2006. The additional indication sought for AB1xbet 온라인IFY is for excitab1xbet 온라인ity associated with autism in juven1xbet 온라인es.
- The prevalence of autism in Japan is between 2 and 20 people per 10,000, and the total number of patients is reported as approximately 21,000. Few treatment options exist for the excitab1xbet 온라인ity that occurs in about 20% of people with autism and new treatment agents that can be safely used for it are eagerly awaited.
- AB1xbet 온라인IFY received approval from the U.S. FDA in 2009 for use in patients with excitab1xbet 온라인ity associated with autism and in Japan three medical societies active in the field of autism specified the high medical need and expectation for the development of new medicines for autism.
Otsuka Pharmaceutical Co., Ltd. has submitted an application for regulatory approval in Japan of the anti-psychotic drug AB1xbet 온라인IFY (generic name is aripiprazole) for the additional indication of excitab1xbet 온라인ity associated with autistic disorder for juven1xbet 온라인es from ages 6 through 17. The proposed dosage form for the indication is AB1xbet 온라인IFY Tablets, 1mg.
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