OSI Submits NDA for Tarceva in Japan

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By: Tim Wright

Editor-in-Chief, Contract Pharma

OSI Pharmaceuticals, Inc. has submitted an NDA in Japan covering the use of Tarceva for the treatment of advanced or recurrent non-small cell lung cancer (NSCLC). The application was submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW) by Chugai Pharmaceutical, Co., Ltd., a Japanese affiliate to Roche and OSI’s international partner for Tarceva. Tarceva is currently approved in the U.S., the EU, and approximately 50 countries worldwide for the treatment of patients with l...

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