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Published on 20 December 2007

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FDA seeks more Cervarix information


GlaxoSmithKline (GSK) has revealed that the US Food & Drug Administration (FDA) has requested more information on its cervical cancer vaccine Cervarix before it will grant the drug marketing approval.

Europe’s largest drug manufacturer had earlier said that it expected to start selling the drug in the United States in 2008.

Analysts believe that Cervarix will eventually become a multibillion-dollar product once it becomes available.

GSK said that it had received a so-called complete response letter, which the FDA issues when the review of a marketing application file has been completed, but questions remain to be answered prior to the drug being approved.

Barbara Howe, GSK’s vice president and director of North American vaccine development, said: “We have already started addressing the questions and will be engaged in discussions with the FDA to finalise our responses.

“Our discussions with the agency continue to be positive and constructive, and we are working diligently to resolve any outstanding questions to bring Cervarix to the US market.”

Copyright © PA Business 2007


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