Vaccines, Blood & Biologics
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Cervarix
STN: BL 125259
Proper Name: Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant
Tradename: Cervarix
Manufacturer: GlaxoSmithKline Biologicals
Indications:
- 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 females 9 through 25 years of age
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Supporting Documents
July 16, 2012 Approval Letter - Cervarix
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
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 (PDF - 372KB)January 14, 2011 Approval Letter - Cervarix
To revise the full prescribing information to reflect the data from the final re-analysis of HPV-008.January 13, 2011 Approval Letter - Cervarix
To include a Patient Package Insert to the full prescribing information.November 23, 2010 Approval Letter - Cervarix
To include that the prefilled syringe presentation with the tip cap may contain natural rubber latexSeptember 2, 2010 Approval Letter - Cervarix
To add lymphadenopathy to the Adverse Reactions, Postmarketing Experience section of the full prescribing information.May 5, 2010 Approval Letter - Cervarix
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 Approval History, Letters, Reviews, and Related Documents - Cervarix Statistical Review and Evaluation - Cervarix (PDF - 87KB)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. (PDF - 145KB)
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Related Information
FDA Approves New Vaccine for Prevention of Cervical Cancer
Press Release: October 16, 2009
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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