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Subscribe To Our Syndicated NewsGardasil Not Approved for Women
-June 26, 2008
According to recent reports, U.S. regulators have told Merck & Co. that their vaccine, Gardasil, cannot be marketing as approved yet for women over the age of 26.
The vaccine has not been granted FDA approval for use in older women to protect against cervical cancer.
Complications Halt Approval
Merck reportedly recently applied for use of Gardasil in women between the ages of 27 and 45.
The FDA issued a letter regarding the application and has said that there are complications that are interfering with its approval within the expected time frame.
“It’s hard to get a feel for if this is a dead issue or if this is delayed,” says Linda Bannister, an analyst for Edward Jones. “At the minimum it’s going to be delayed.”
Gardasil Fails Approval in Other Areas
Merck reportedly failed to win approval by the FDA in the past when they requested the expansion of Gardasil to protect against other strains of the Human Papillomavirus.
The company has since dismissed its efforts for approval for other strains of the virus known to cause cancer.
Gardasil Details
Gardasil was approved in 2006 to help prevent cervical cancer and genital warts in females between the ages of nine and 26.
Since its approval, the vaccine has become one of Merck’s top selling products and has helped the company recover after the much publicized recall of Vioxx.
(Source: Reuters)
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