Pharmaceutical company Merck & Co., Inc. announced recently that it submitted a Biologics License Application (BLA) for a quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine for cervical cancer, to the US Food and Drug Administration (FDA). Merck also announced that it has plans to submit for licensure the Merck vaccine 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 the cervical cancer vaccine. Under the Prescription Drug User Fee Act (PDUFA), for standard BLAs filed in 2005, the FDA’s goal is to review and act on 90 percent of BLAs within 10 months of receipt, and to review and act on BLAs designated for priority review within six months of receipt.
The vaccine is one of three late-stage vaccines at Merck. In April, 2005, the company submitted Biologics License Applications to the FDA for a vaccine for rotavirus gastroenteritis, and a vaccine for zoster (shingles).
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