WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Feb. 7, 2006--Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for GARDASIL(R) (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) and that the investigational cervical cancer vaccine will be given priority review by the agency. A priority designation is intended for products that address unmet medical needs. Under the Prescription Drug User Fee Act (PDUFA), for BLAs filed in 2005, the FDA’s goal is to review and act on BLAs designated as priority review within six months of receipt. The FDA has informed Merck that the review goal date is June 8, 2006.
