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Eisai, Astellas Experience Delays In Seeking U.S. Drug Approvals

This article was originally published in PharmAsia News

Executive Summary

Eisai and Astellas Pharma separately announced delays in seeking U.S. approval for new drugs, Eisai for more than a year. Eisai said the decision to put off applying for its E7389 (eribulin mesylate) cancer drug would affect the company's long-term business goals. But President Haruo Naito added the company expects to garner more sales at the beginning of its eventual marketing effort as a result. Astellas said it would delay filing for a new formulation of its Prograf (tacrolimus) as a liver transplant immunosuppressant by three months because the U.S. FDA said it needed that time to review the application. (Click here for more
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