OSI Pharma Inc. (OSIP) and Genentech Inc. (DNA), a wholly owned member of the Roche Group, announced that U.S. FDA has extended the review period for the supplemental New Drug Application for Tarceva as a first-line maintenance therapy in advanced non-small cell lung cancer by an additional 90 days. The extension followed OSI Pharma's submission of further data in support of the application.
The original Prescription Drug User Fee Act date was January 18. The companies now anticipate FDA action on the supplemental New Drug Application by April 18, 2010.
OSI Pharma and Genentech will work closely with the FDA during the extended review period.
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