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news.Merck & Co. has announced that the FDA has accepted, and designated for priority review, the supplemental biologics license application for Gardasil for the potential use in women aged 27 through 45.
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A priority designation is intended for products or indications that address unmet medical needs. Under the Prescription Drug User Fee Act, the FDA’s goal is to review and act on 90% of biologics license applications designated as priority review within six months of receipt.
Gardasil is currently indicated for girls and women nine through 26 years of age for the prevention of cervical cancer, precancerous or dysplastic lesions, and genital warts caused by human papillomavirus types 6, 11, 16 and 18.