Merck Dealt Setback, FDA Rejects Gardasil For Older Women

June 26, 2008

Merck & Co. has received quite a setback at the hands of the the U.S. Food and Drug Administration, as they have refused to accept the expanded use of the cervical cancer vaccine Gardasil for older womenBoston (ChattahBox) – Merck & Co. has received quite a setback at the hands of the the U.S. Food and Drug Administration, as they have refused to accept the expanded use of the cervical cancer vaccine Gardasil for older women.

The FDA sent a letter to Merck which stated they cannot yet accept Gardasil for use by older women aged 27 through 45.

Merck was banking on an approval to come by July, and expected huge annual sales to come from the expanded approval.

The FDA stated that they had come across issues with the approval of Gardasil for older women, which will force them to miss the review time frame and look further at the vaccine.

Merck said that the issues found by the FDA have no impact at all on Gardasil for women aged 9 through 26.

Gardasil protects against four types of HPV, two of which are the leading causes of cervical cancer.


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