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www.fdanews.com/articles/81054-osi-pharmaceuticals-announces-tarceva-r-granted-approval-in-the-european-union

OSI PHARMACEUTICALS ANNOUNCES TARCEVA(R) GRANTED APPROVAL IN THE EUROPEAN UNION

September 21, 2005

OSI Pharmaceuticals, Inc. (NASDAQ:OSIP) announced today that its international partner for Tarceva(R) (erlotinib), Roche, received approval from the European Commission of Tarceva for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Tarceva is an oral tablet indicated for daily administration, and is approved in the United States, Canada, and Switzerland. Tarceva is the only epidermal growth factor receptor (EGFR) therapy to demonstrate in a Phase III trial an increase in survival for advanced NSCLC patients.

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