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July 19, 2011 Approval Letter - Cervarix

Our STN: BL 125259/132     

 
GlaxoSmithKline Biologicals, Inc.
Attention: Matthew Whitman
2301 Renaissance Boulevard, Building 510
King of Prussia, PA 19406-2772
 
Dear Mr. Whitman:
 
We have approved your request to supplement your biologics license application for Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant to include safety and immunogenicity data to support use in females as young as 9 years of age.  
 
The review of this product was associated with the following National Clinical Trial (NCT) number: NCT00541970.
 
Under 21 CFR 201.57(c)(18), patient labeling must be reprinted at the end of the package insert. We request that the text of information distributed to patients be printed in a minimum of
10-point font.
 
Please provide your final content of labeling in Structured Product Labeling (SPL) format and include the carton and container labels. In addition, please submit three original paper copies for carton and container final printed labeling. All final labeling should be submitted as Product Correspondence to this BLA at the time of use (prior to marketing) and include implementation information on FDA Form 356h.
 
In addition, please submit the final content of labeling (21 CFR 601.14) in SPL format via the FDA automated drug registration and listing system, (eLIST), as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
Information on submitting SPL files using eLIST may be found in the guidance for industry titled, “SPL Standard for Content of Labeling Technical Qs and As at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation
/Guidances/UCM072392.pdf
.
 
You may submit two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. You must submit copies of your final advertisement and promotional labeling at the time of initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR 601.12(f)(4)).
 
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence or substantial clinical experience to support such claims (21 CFR 202.1(e)(6)).
 
Please submit an amendment to all pending supplemental applications for this BLA that include revised labeling incorporating a revised content of labeling that includes these changes.
 
POSTMARKETING COMMITMENTS
 
Postmarketing study subject to reporting requirements of 21 CFR 601.70
 
With the approval of this supplement, to include use in girls 9 years of age, we are formally releasing you from PMC #3 as identified in the October 16, 2009, approval letter for this license application:
 
PMC#3
To conduct an observational study in a U.S. managed care organization to evaluate the incidence of new onset autoimmune disease among at least 50,000 CERVARIX recipients. The final protocol will be submitted by March 2010. Projected completion of patient accrual, subject to vaccine uptake, will be completed by March 2013. Projected study completion, subject to vaccine uptake, will be completed by September 2014. The final study report is projected to be submitted by March 2015 (6 months after study completion).
 
We acknowledge your written commitments as described in your email correspondence dated June 16 and June 22, 2011, as outlined below:
 
1)  To conduct an observational study in a U.S. managed care organization to evaluate the incidence of new onset autoimmune disease among at least 50,000 CERVARIX recipients 9 through 25 years of age.

  •        Final Protocol Submission: September 30, 2011
  •        Study Completion Date: September 30, 2014
  •        Final Report Submission: March 31, 2015 
     
2) To submit the final study report for study HPV-029. This study is completed. The final clinical study report will be submitted by October 31, 2011.
 
3) To submit the final study report for study HPV-030. This study is completed. The final clinical study report will be  submitted by October 31, 2011.
 
We will include information contained in the above-referenced supplement in your biologics license application file.
 
Sincerely yours,
 
Wellington Sun, MD
Director
Division of Vaccines and
 Related Products Applications
Office of Vaccines
 Research and Review  
Center for Biologics
 Evaluation and Research