FDA Denies Approval Of Gardasil For Older Women, But Why?

Washington (dbTechno) - The U.S. Food and Drug Administration (FDA) has denied approval of the Merck & Co. cervical cancer vaccine Gardasil for older women, stating that they want more data from the drug maker.

The FDA refused to approve Gardasil for women aged 27 to 45 in their latest decision, sending Merck back to do more work.

Health regluators in the U.S. have now asked Merck to submit more data on the effectiveness of the vaccine.

They are going to be awaiting a 48-month study to be completed on the vaccine, and once that is done, the FDA will go back and look at possibly approving it once again.

This is the second time that the FDA has refused to approve the vaccine.

Back in June, health regulators stated that again they needed more data before it was approved for older women.

Gardasil was first approved back in 2006 to treat young women between the ages of 9 and 26.

The vaccine prevents cervical cancer, as well as genital warts by preventing the human papillomavirus (HPV), which causes the majority of cervical cancer cases.

Merck is confident this decision will have no impact on their sales or earnings for the year 2009.

They are also still working to have Gardasil approved for men.