Tarceva’s PDUFA date extended (NASDAQ:OSIP)
Jay Garcilazo (January 20th, 2010) Writes:
Tarceva – which is the brand name for the generic drug erlotinib – is co-marketed by OSI Pharmaceuticals, Inc. (NASDAQ:OSIP) and Roche Holding AG (NASDAQ:RHHBY). Both companies have already submitted a special type of application – known as the Supplemental new drug application (sNDA) – regarding Tarceva to the United States of America’s Food & Drug Administration. Upon receiving the application, the FDA has given OSI Pharma and Roche Holdings AG a Prescription Drug User Fee Act date (also called Action date or just PDUFA date). This was the date on which the Food & Drug Administration must respond to the companies’ application. According to OSI Pharma, the initial PDUFA date for Tarceva was January 18, 2010. However, on January 15, 2010, the corporation disclosed that the United States of America’s one of the toughest regulators, the Food and Drug Administration, has delayed the PDUFA date by 90 days.
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out-quarter doesn't seem to be impressing investors today, as 
