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GlaxoSmithKline
GlaxoSmithKline Responds to FDA on CERVARIX and Plans to Submit Final Study Data for Approval
July 16th, 2008
GlaxoSmithKline (NYSE:GSK) today provided the following update regarding its application to the U.S. Food and Drug Administration (FDA) for approval of CERVARIX(R), its vaccine to prevent cervical cancer. GSK has submitted its response to questions raised by the FDA in their Complete Response Letter, received in December, 2007. In addition, given that final data from GSK's Phase III pivotal efficacy study, HPV-008, are 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. GSK anticipates submitting these data in the first half of 2009. The timing depends on...
Source: Vaccine Weekly (2008-07-16)
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