Friday, March 28, 2008
FDA Grants Priority Review of Cervical Cancer Vaccine For Adult Women
Reuters: FDA grants fast review of Gardasil for adult women (3/19):
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.