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Gardasil Approval History

  • FDA approved: Yes (First approved June 8th, 2006)
  • Brand name: Gardasil
  • Generic name: human papillomavirus quadrivalent (types 6, 11, 16, and 18) vaccine, recombinant
  • Dosage form: Injection
  • Company: Merck & Co., Inc.
  • Treatment for: Human Papillomavirus Prophylaxis

Gardasil (human papillomavirus vaccine) is a recombinant vaccine indicated for the prevention of cervical, vulvar, and vaginal cancers caused by human papillomavirus (HPV) in girls and women 9 through 26 years of age. Gardasil is also approved for the prevention of genital warts caused by HPV types 6 and 11 in boys and men 9 through 26 years of age.

Development History and FDA Approval Process for Gardasil

Dec 22, 2010Approval FDA: Gardasil Approved to Prevent Anal Cancer
Oct 16, 2009Approval FDA Approves Gardasil for Use in Boys and Young Men
Sep 15, 2008Approval FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers
Jun  8, 2006Approval FDA Approves Gardasil for Prevention of Cervical Cancer other HPV-related Diseases
May 18, 2006FDA Advisory Committee Votes Unanimously That Clinical Data Support the Efficacy and Safety of Gardasil
Feb  7, 2006Gardasil, Merck's Investigational Cervical Cancer Vaccine, to Receive Priority Review from the U.S. Food and Drug Administration
Feb  2, 2006Biologics License Application for Gardasil, Merck's Investigational Cervical Cancer Vaccine, Is On Track
Dec  5, 2005Merck Submits Biologics License Application to FDA for Gardasil, the Company's Investigational Vaccine for Cervical Cancer

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