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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
  • Dosage form: Injection
  • 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).

Development History and FDA Approval Process for Cervarix

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 SubmitFinal Study Data for Approval
Dec 17, 2007GlaxoSmithKline Receives FDA 'Complete Response' Letterfor Cervarix Cervical Cancer Vaccine
Mar 29, 2007GlaxoSmithKline Submits Biologics License Application to U.S. Foodand Drug Administration for Cervarix

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