Glaxo Vaccine Cervarix Hit With Delay In FDA Approval

July 1, 2008

GlaxoSmithKline PLC has come out and stated that they do not expect their cervical cancer vaccine, Cervarix, to receive FDA approval before 2009....Washington (ChattahBox) – GlaxoSmithKline PLC has come out and stated that they do not expect their cervical cancer vaccine, Cervarix, to receive FDA approval before 2009.

GlaxoSmithKline has stated that they have responded to all of the questions posed to them by the FDA, but still wants to add further data to the FDA review through a new trial.

The new clinical trial will last through the first half of 2009, which is when the FDA will receive the added information.

Glaxo has stated that this means the FDA approval will likely not come until the second half of 2009, as a review takes 6 months to complete usually.

This comes as Glaxo prepares to compete with Merck & Co. as they have the rival cervical cancer vaccine, Gardasil.


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