Gardasil approval delayed for use in women ages 27 – 45
Merck & Co., Inc. Receives Complete Response Letter from the Food and Drug Administration for Use of GARDASIL? in Women Ages 27 through 45 – Merck & Co., Inc. announced that the U.S. Food and Drug Administration has issued a second complete response letter regarding the supplemental biologics license application (sBLA) for the use of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant] in women ages 27 though 45.