Biologics License Application For Gardasil(R), Merck & Co., Inc.'s Investigational Cervical Cancer Vaccine, Is On Track
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Feb. 2, 2006--Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) Biologics License Application (BLA) for GARDASIL(R) (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) is on track and pending acceptance. Merck delivered the completed file to the FDA on December 1. Following the submission, the FDA informed Merck that the submission date is officially December 8. Within 60 days following official submission, the FDA will determine whether it will accept for review Merck's application as submitted.