GlaxoSmithKline Cervarix Vaccine Faces FDA Approval Delays

Washington (dbTechno) – GlaxoSmithKline PLC has come out and stated that a review of their cervical cancer vaccine Cervarix by the FDA will take longer than expected. U.S. approval of the cervical cancer vaccine has been delayed due to the fact that Glaxo wants to add more data to the review.

GlaxoSmithKline has since stated that they do not expect the FDA to reach a decision as to whether or not they will approve Cervarix until the latter half of 2009.

This is not the first delay, as the FDA actually delayed the review of Cervarix in the past as well, when they requested Glaxo to add more information about the vaccine.

Glaxo put out a statement on Monday that they have answered all of the questions posed to them by the FDA, but has also added more information on top of what is asked.

The added information is from a clinical trial that will end by the end of this year.

Glaxo submitted intermin data for the time being, and will add data in the first half of 2009.

The delay will likely mean nothing but more positive sales for Merck & Co. as they have the rival cervical cancer vaccine, Gardasil.

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