Merck & Co., Inc.

Gardasil, a cervical cancer vaccine, to receive priority review from the U.S. FDA

Published in Oncology Business Week, March 12th, 2006

Merck & Co., Inc., announced that the U.S. Food & Drug Administration (FDA) has accepted the biologics license application (BLA) for Gardasil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) and that the investigational cervical cancer vaccine will be given priority review by the agency.

A priority designation is intended for products that address unmet medical needs. Under the Prescription Drug User Fee Act, for BLAs filed in 2005, the FDA's goal is to review and act on BLAs designated as priority review within 6 months of receipt.

The FDA has informed Merck the review goal date is June 8, 2006.

Since...

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Source: Oncology Business Week (2006-03-12)

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