Proper Name:Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
Manufacturer: GlaxoSmithKline Biologicals
- Prevention of cervical cancer, cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ, and cervical intraepithelial neoplasia (CIN) grade 1, caused by oncogenic human papillomavirus (HPV) types 16 and 18, in females9 through 25 years of age
April 25, 2016 Approval Letter - Cervarix(PDF - 28KB)
To change the product labeling in accordance with the guidance for industry issued on December 2, 2014, titled, “Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex.
February 13, 2015 Approval Letter - CERVARIX July 17, 2014 Summary Basis for Regulatory Action - CERVARIX(PDF - 91KB) July 21, 2014 Approval Letter - CERVARIX
To include efficacy and immunogenicity data from the end-of-study analyses of Study HPV-008 in the package insert and to update the pharmacovigilance plan.
November 5, 2013 Approval Letter - Cervarix - ARCHIVED
Language in the package insert addressing the presence of natural rubber latex in the pre-filled syringe tip cap
March 8, 2013 Approval Letter -CERVARIX - ARCHIVED
To include changes to the package insert reflect the discontinuation of the vial presentations.
July 16, 2012 Approval Letter - Cervarix - ARCHIVED
Updated information regarding instruction on the method of vaccine administration in the Dosage and Administration section of the package insert.
Summary Basis for Regulatory Action-Cervarix(PDF - 67KB) July 19, 2011 Approval Letter - Cervarix - ARCHIVED
To include safety and immunogenicity data to support use in females as young as 9 years of age.
Clinical Review of Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant, Biologics License Application Efficacy Supplement, July 14, 2011 - Cervarix - ARCHIVED January 14, 2011 Approval Letter - Cervarix - ARCHIVED
To revise the full prescribing information to reflect the data from the final re-analysis of HPV-008.
January 13, 2011 Approval Letter - Cervarix - ARCHIVED
To include a Patient Package Insert to the full prescribing information.
November 23, 2010 Approval Letter - Cervarix - ARCHIVED
To include that the prefilled syringe presentation with the tip cap may contain natural rubber latex
September 2, 2010 Approval Letter - Cervarix - ARCHIVED
To add lymphadenopathy to the Adverse Reactions, Postmarketing Experience section of the full prescribing information.
May 5, 2010 Approval Letter - Cervarix - ARCHIVED
Revise: To request that the pre-filled syringe cartons contain language stating that the tip cap and rubber plunger contain dry natural latex rubber.
October 16, 2009 Approval Letter - Cervarix Summary Basis of Regulatory Action - Cervarix(PDF - 178KB) Summary Basis of Regulatory Action Errata - Cervarix - ARCHIVED Approval History, Letters, Reviews, and Related Documents - Cervarix[ARCHIVED] Statistical Review and Evaluation - Cervarix - ARCHIVED APPENDIX 1: Primary and secondary immunogenicity objectives in study HAV-048 and respective results which did not provide support for approval of supplement are included in Appendix 1 - ARCHIVED
FDA Approves New Vaccine for Prevention of Cervical Cancer - ARCHIVED
Press Release: October 16, 2009