Women's Health Weekly
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Cervical Cancer
Pharma company submits biologics license application for papillomavirus vaccine to U.S. FDA
January 5th, 2006
Merck & Co., Inc. announced that the company submitted a biologics license application (BLA) for Gardasil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) to the U.S. Food & Drug Administration (FDA). Merck also announced that it has plans to submit for licensure of Gardasil in the European Union and Australia, as well as other agencies, in early 2006. Within 60 days following submission, the FDA will determine whether it will accept for review Merck's application as submitted. Merck is seeking priority review designation for Gardasil. Under the Prescription Drug User Fee Act (PDUFA), for standard BLAs filed in 2005, the...
Source: Women's Health Weekly (2006-01-05)
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