Merck: Cervical cancer vaccine on track

WHITE HOUSE STATION, N.J., Feb. 2 (UPI) -- Merck said Thursday its application for its pending cervical-cancer vaccine Gardasil is on track.

The firm said that its biologics license application submitted to the Food and Drug Administration for Gardasil -- a quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine -- is "on track and pending acceptance."

The company said in a statement Thursday that it delivered the completed file to the FDA Dec. 1.

Following the submission, Merck said the FDA informed the company that the submission date is officially Dec. 8.

Within 60 days following the official submission, the agency will determine whether it will accept for review Merck's application as filed, Merck said.