Merck & Co., Inc. Provides Update on Status of Supplemental Biologics License Applications (sBLA) for GARDASIL(R)
Published: Jun 21, 2007
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. announced today that the Food and Drug Administration (FDA) has accepted for standard review a supplemental Biologics License Application (sBLA) for GARDASIL [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine]. The sBLA includes data on protection against vaginal and vulvar cancer caused by HPV types 16 and 18 and data on immune memory. Under the Prescription Drug User Fee Act (PDUFA), for standard sBLAs filed in 2007, the FDA’s goal is to review and act on 90 percent of sBLAs within 10 months of receipt. Merck anticipates action by the FDA in the first quarter of 2008.