OSI Pharmaceuticals, Inc. Announces Acceptance of Tarceva Supplemental New Drug Application for Review by the U.S. FDA

MELVILLE, N.Y.--(BUSINESS WIRE)--OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental New Drug Application (sNDA) for the use of Tarceva® (erlotinib) as a first-line maintenance treatment for patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy. Based upon the March 17th receipt of filing the FDA Prescription Drug Fee Act (PDUFA) review date will be on or about January 18, 2010.