FDA approves Merck’s Gardasil

The FDA last week approved Merck’s Gardasil, the first vaccine developed to prevent cervical cancer caused by human papillomavirus. Gardasil was evaluated and approved in six months under FDA's priority review process designed for products with potential to provide significant health benefits. The vaccine is approved for use in females 9-26 years of age. The FDA's Vaccines and Related Biological Products Advisory Committee late last month unanimously recommended the approval of the drug. Analysts have predicted sales of Gardasil could reach the $1.5 billion mark—a figure that could help a beleaguered Merck offset some of the losses it incurred following the withdrawal of its $2.5 billion painkiller Vioxx.

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