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Roche To Launch Actemra In Japan, India Ahead Of U.S., EU

This article was originally published in PharmAsia News

Executive Summary

Swiss drug maker Roche plans to launch its new-generation rheumatoid arthritis drug Actemra (tocilizumab) first in Japan and then in India. The company bypassed the United States because U.S. FDA has delayed approval over safety, production and labeling issues. As a result, Roche decided to have its Japanese arm, Chugai, launch the drug in Japan and its Roche Scientific arm in India. The FDA requested Chugai and Roche to conduct new animal trials to be sure Actemra would not affect pregnancy or fertility in people. India's DCGI approved the drug only for rheumatoid arthritis at the discretion of a physician. (Click here for more



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