Merck says FDA to decide on wider Gardasil use
NEW YORK, June 20 (Reuters) - Merck & Co. (MRK.N) said on Wednesday it expects U.S. health regulators to decide in the first quarter of 2008 whether to allow the company to market its vaccine Gardasil for protection against vaginal and vulvar cancer.
Gardasil, which protects against several strains of Human Papillomavirus, is approved as a vaccine to prevent cervical cancer caused by the virus for use in girls and women ages 9 to 26. The company is seeking a similar expanded label with European regulators.
Merck said the U.S. Food and Drug Administration had agreed to a standard review period for the expanded indication, which usually takes about 10 months. A priority review would have cut the decision time to six months.
((Reporting by Bill Berkrot; Reuters Messaging: bill.berkrot.reuters.com@reuters.net phone 646 223-6030)) Keywords: MERCK GARDASIL/
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