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Gardasil HPV-Vaccine Not Granted for Use in Adult Women

Press Release

 

U.S. Prescribing Information for GARDASIL® Updated; Indication Not Granted for Use in Adult Women

 

WHITEHOUSE STATION, NJ - April 6, 2011 - Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has completed its review of Merck's supplemental biologics license application (sBLA) for an indication to use GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in women ages 27-45. An indication for adult women was not granted; instead, the Limitations of Use and Effectiveness for GARDASIL was updated to state that GARDASIL has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age. End of study data from the clinical study evaluating the use of the vaccine in this age group was also added to the prescribing information.


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