Gardasil
human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant
Treatment for Human Papillomavirus ProphylaxisBiologics License Application for Gardasil, Merck's Investigational Cervical Cancer Vaccine, Is On Track
WHITEHOUSE STATION, N.J., February 2, 2006 -- Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) Biologics License Application (BLA) for Gardasil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant vaccine) is on track and pending acceptance. Merck delivered the completed file to the FDA on December 1. Following the submission, the FDA informed Merck that the submission date is officially December 8. Within 60 days following official submission, the FDA will determine whether it will accept for review Merck's application as submitted.
Source: Merck & Co., Inc.
Related Articles:
FDA Approves Gardasil for Use in Boys and Young Men - October 16, 2009
FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers - September 15, 2008
FDA Approves Gardasil for Prevention of Cervical Cancer other HPV-related Diseases - June 8, 2006
FDA Advisory Committee Votes Unanimously That Clinical Data Support the Efficacy and Safety of Gardasil - May 18, 2006
Gardasil, Merck's Investigational Cervical Cancer Vaccine, to Receive Priority Review from the U.S. Food and Drug Administration - February 7, 2006
Merck Submits Biologics License Application to FDA for Gardasil, the Company's Investigational Vaccine for Cervical Cancer - December 5, 2005
New Drug Applications Archive
2008: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2004: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
