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FDA Restricts Gardasil Market
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packexpo.com
June 27, 2008
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The drug maker Merck & Co. said Wednesday that the Food and Drug Administration has rejected expanding the use of the cervical cancer vaccine Gardasil to include women ages 27 to 45.

The agency cited "issues that preclude approval" within the expected review time frame, Merck said.

Gardasil was approved in 2006 for girls and women between 9 and 26 years old to prevent cervical cancer caused by the human papillomavirus. The agency's current action does not affect this population's use.

The FDA decision bars Merck from marketing Gardasil to women ages 27 to 45, but does not prevent those women from getting the vaccine from their doctors.

Merck said that the agency identified several issues related to the application in a "complete response" letter, including stating that the data submitted does not support extending Gardasil's use to include non-vaccine HPV types.

Merck also reaffirmed its goal of attaining compound annual growth of between 4 percent and 6 percent from 2005 through 2010.

Gardasil is the only cervical cancer vaccine approved for the lucrative U.S. market. It is outselling another vaccine, Cervarix, from GlaxoSmithKline PLC, in worldwide sales, analysts said, garnering more than $1 billion in sales since its June 2006 U.S. launch.

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