FDA rejects Gardasil vaccine for older women

June 25, 2008 2:41:07 PM PDT
US regulators have told Merck and Company it cannot market its cervical cancer vaccine Gardasil to older women. Merck had applied for the use of Gardasil in women ages 27 through 45.

The US FDA said in a letter regarding the applications that it has completed its review and there are issues that preclude approval within the expected review time frame.

Merck said it also failed to win FDA approval to expand Gardasil to protect against more strains of the human papillomavirus, which causes cervical cancer.


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