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Gardasil Clears FDA, But Dosing May Pose Administrative Challenges

Executive Summary

Administration of Merck's recently approved human papillomavirus vaccine Gardasil at the recommended schedule of zero, two and six months may pose a logistical challenge to vaccinating adolescents

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Merck’s Gardasil encounters FDA roadblock

Merck received two "complete response" letters to sBLAs for its human papilloma virus vaccine Gardasil for women ages 27 to 45 and for cross-protection, the firm announces June 25. Merck says it will respond to the complete response for older women in July. That application was given priority review in March. However, FDA has indicated data do not support extending the label to include cross-protection. Gardasil was approved in girls and women ages 9 to 26 in 2006 (1"The Pink Sheet," June 12, 2006, p. 3)

Merck’s Gardasil encounters FDA roadblock

Merck received two "complete response" letters to sBLAs for its human papilloma virus vaccine Gardasil for women ages 27 to 45 and for cross-protection, the firm announces June 25. Merck says it will respond to the complete response for older women in July. That application was given priority review in March. However, FDA has indicated data do not support extending the label to include cross-protection. Gardasil was approved in girls and women ages 9 to 26 in 2006 (1"The Pink Sheet," June 12, 2006, p. 3)

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