Gardasil supplemental application gets priority review designation

April 1, 2008

Merck & Co., Inc.’s supplemental Biologics License Application for use of Gardasil in women aged 27 through 45 has been accepted by the FDA and designated for priority review.

WHITEHOUSE STATION, New Jersey-Merck & Co., Inc.’s supplemental Biologics License Application for use of Gardasil in women aged 27 through 45 has been accepted by the FDA and designated for priority review. Gardasil [human papillomavirus quadrivalent (types 6, 11, 16, 18) vaccine, recombinant] is currently indicated for girls and women age 9 through 26 for the prevention of cervical cancer, precancerous or dysplastic lesions, and genital warts caused by HPV types 6, 11, 16, and 18.