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Cervarix Approval History

  • FDA approved: Yes (First approved October 16th, 2009)
  • Brand name: Cervarix
  • Generic name: human papillomavirus bivalent (types 16 and 18) vaccine, recombinant
  • Company: GlaxoSmithKline
  • Treatment for: Human Papillomavirus Prophylaxis

Cervarix (human papillomavirus bivalent (types 16 and 18) is a is a preventative cervical cancer vaccine for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 in girls and young women (aged 10-25).

FDA Approval History for Cervarix

DateArticle
Oct 16, 2009Approval FDA approves Cervarix, GlaxoSmithKline's cervical cancer vaccine
Sep  9, 2009FDA Advisory Committee Makes Favorable Recommendation for Cervarix, GlaxoSmithKline's Candidate Cervical Cancer Vaccine
Mar 30, 2009Cervarix U.S. Regulatory Update
Jun 30, 2008GlaxoSmithKline Responds to FDA on Cervarix and Plans to Submit Final Study Data for Approval
Dec 17, 2007GlaxoSmithKline Receives FDA 'Complete Response' Letter for Cervarix Cervical Cancer Vaccine
Mar 29, 2007GlaxoSmithKline Submits Biologics License Application to U.S. Food and Drug Administration for Cervarix

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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