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www.fdanews.com/articles/74302-tarceva-granted-canadian-approval-for-treatment-of-lung

TARCEVA GRANTED CANADIAN APPROVAL FOR TREATMENT OF LUNG

July 14, 2005

OSI Pharmaceuticals, Inc. (Nasdaq:OSIP) announced today that Health Canada has approved Tarceva(R) (erlotinib) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following failure of first or second-line chemotherapy. Tarceva is approved in the United States and in Switzerland and had received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending approval of Tarceva for the treatment of patients with advanced NSCLC. An approval decision by the European Commission is anticipated over the next several months. Tarceva is an oral tablet indicated for daily administration.

PharmaLive (http://www.medadnews.com/News/index.cfm?articleid=256036)