GSK Responds to FDA Inquiry for Cervarix

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By: Tim Wright

Editor-in-Chief, Contract Pharma

GlaxoSmithKline has submitted its response to questions raised by the FDA regarding its application for approval of Cervarix, its vaccine to prevent cervical cancer.     GSK will also submit Phase III efficacy study data from HPV-008, which is expected to be available later this year. GSK has decided to augment its application for approval with these data to ensure they are included in the U.S. label. The company anticipates submitting these data in the first half of 2009 and FDA action is ex...

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