WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. announced today that the US Food and Drug Administration (FDA) has issued a complete response letter regarding the supplemental biologics license application (sBLA) for the use of GARDASIL® in women ages 27 though 45. The agency issued the letter to advise that it has completed its review of the submission and that there are issues that preclude approval of the supplement within the expected review timeframe. Merck has already discussed with FDA their questions related to this application and expects to respond to the Agency in July. Merck submitted the sBLA for use in this expanded population in January of this year and in March the FDA designated the submission a priority review. The letter does not affect current indications for GARDASIL in females aged 9 through 26.
