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The FDA has extended the review period for OSI Pharmaceuticals and Genentech’s sNDA for Tarceva (erlotinib) as a first-line maintenance therapy in advanced non-small cell lung cancer (NSCLC) by an additional 90 days.
January 18, 2010
By: Tim Wright
Editor-in-Chief, Contract Pharma
The FDA has extended the review period for OSI Pharmaceuticals and Genentech’s sNDA for Tarceva (erlotinib) as a first-line maintenance therapy in advanced non-small cell lung cancer (NSCLC) by an additional 90 days. The extension follows OSI’s submission of further data in support of the application. The original Prescription Drug User Fee Act (PDUFA) date was January 18, 2010. The companies now anticipate FDA action by April 18, 2010....
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