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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Merck's Gardasil vaccine for cervical cancer received approval for prevention of vaginal and vulvar cancer caused by human papilloma virus types 16 and 18, FDA announces Sept. 12. The extended indication still applies to the same age range, women nine to 26. In June, the firm received two "complete response" letters for sBLAs seeking approval for women ages 27 to 45 (1"The Pink Sheet," June 30, 2008, In Brief). Gardasil's label has been revised to note that presently available data is insufficient to support use beyond age 26, and information has been added showing that the vaccine does not protect against diseases caused by HPV types excluded from the vaccine
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