Wednesday, March 19, 2008

Cervical cancer vaccine put on fast track for review by FDA


Elkhorn, CO
Merck & Co on Wednesday said U.S. regulators have granted a priority review for the company's application to expand marketing of its Gardasil cervical cancer vaccine to women aged 27 through 45.

The designation means that the U.S. Food and Drug Administration is expected to make its decision on the marketing application within 6 months, rather than within the agency's typical 10-month review period.

Gardasil, one of Merck's fastest-growing products, is currently approved for girls and women nine through 26 years of age. It works by preventing infection with four sexually transmitted strains of the Human Papillomavirus that cause most cases of cervical cancer. More >>
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