Food & Drug Law Weekly
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OSI Pharmaceuticals, Inc.
Pharma company and Roche announce filing Tarceva with European Authorities
September 24th, 2004
OSI Pharmaceuticals, Inc., (NASDAQ: OSIP) announced that its international partner, Roche, submitted a marketing authorization application to the European Health Authorities for Tarceva (erlotinib HCl) as a monotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC) for whom chemotherapy has failed. Tarceva is currently being evaluated in an extensive clinical development program by a global alliance among OSI, Genentech, and Roche. This European Union (EU) filing, as well as the previously completed submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of Tarceva, are...
Source: Food & Drug Law Weekly (2004-09-24)
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