No approval from FDA for age expansion of Merck's HPV vaccine

6/26/2008

NEW YORK Merck has failed, for now, to win approval from the Food and Drug Administration to market its human papillomavirus vaccine Gardasil to women aged 27 to 45, the company announced Wednesday.

The FDA also denied approval for use of Gardasil to treat other strains of HPV, or genital warts, which causes cervical cancer in women. It originally approved the drug in June 2006 for guarding against HPV in girls and women aged 9 to 26.

Gardasil, known generically as human papillomavirus quadrivalent vaccine, recombinant, had sales of $1.5 billion in 2007, according to Merck financial data.

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