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FDA expands Gardasil uses, but not users

Executive Summary

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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