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Dainippon Sumitomo Prepares 2011 Schizophrenia Drug Launch In The U.S.

This article was originally published in PharmAsia News

Executive Summary

Major Japanese drug maker Dainippon Sumitomo will establish a holding company in the U.S. in July to prepare for an NDA submission to U.S. FDA for novel schizophrenia drug lurasidone (SM-13496). The company plans to submit the NDA for the antipsychotic agent with FDA in the first half of 2010, said President Masayo Tata, June 15. According to Dainippon Sumitomo, late-stage clinical trials for lurasidone resulted in promising results in confirming the drug's efficacy and safety, which prompted the company to move up the planned launch date in the U.S. from 2012 to 2011. (Click here for more - Japanese Language



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