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June 9, 2011 Approval Letter - FluLaval

Our STN: BL 125163/176

ID Biomedical Corporation of Quebec
Attention: Marisha A. Stanislaus, Ph.D.
GlaxoSmithKline Biologicals
US Regulatory Affairs
2301 Renaissance Boulevard, Building 510
P.O. Box 61540
King of Prussia, PA 19406-2772


Dear Dr. Stanislaus: 

We have approved your request to supplement your biologics license application (BLA) for FluLaval®, Influenza Virus Vaccine, to include data from a clinical endpoint study and a non-inferiority immunogenicity study conducted in adults in the prescribing information. 

 
We licensed FluLaval on October 5, 2006, under the accelerated approval regulations. However, because the results of your clinical endpoint study did not demonstrate adequate effectiveness of FluLaval, the accelerated approval commitment (21 CFR 601.41) to verify clinical benefit has not been fulfilled and must be pursued as outlined later in this letter.
 
The data included in the prescribing information were derived from clinical studies referenced in our letters of January 2, 2008, and July 9, 2009, indicating that the following postmarketing commitments stated in the October 5, 2006, approval letter have been fulfilled: 1) To conduct a comparative safety and immunogenicity study of FluLaval and Fluzone® in persons 50 years of age and older, and 2) To conduct a placebo-controlled clinical endpoint study of FluLaval in persons 18-49 years of age. 

The review of this product was associated with the following National Clinical Trial (NCT) number(s): NCT00232947 and NCT00216242.
 
Please note that the carton and container labels for the 2011-2012 United States formulation of FluLaval are being reviewed along with your annual strain change supplement under
-------(b)(4)-------. Please note that the revised prescribing information cannot be used until the above mentioned supplement for 2011-2012 Unites States formulation is approved.
 
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 and FDA Form 2567 as appropriate.
 
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
.
 
If applicable, please submit the approved label as an amendment to all currently pending supplemental applications for this BLA that include a revised content of labeling.
 
ACCELERATED APPROVAL REQUIRED STUDY

Under the accelerated approval of biological products regulations, 21 CFR 601.41, we require that you study FluLaval further to verify and describe its clinical benefit.  We acknowledge your written commitment as described in your correspondence dated May 27, 2011, as outlined below: 
 
1.     To complete ongoing Study FLU Q-QIV-006, a non-influenza vaccine comparator-controlled clinical endpoint study of FLU Q-QIV (quadrivalent seasonal influenza vaccine produced using the FluLaval process) in persons 3 to 8 years of age. 
 
  • Study Completion: March 31, 2013
  • Final Report Submission: March 31, 2014
 
You must conduct this study with due diligence.  If postmarketing studies fail to verify that clinical benefit is conferred by FluLaval or are not conducted with due diligence, we may, following a hearing in accordance with 21 CFR 601.43(b), withdraw or modify approval.
 
Please submit clinical protocols to your IND, with a cross-reference letter to this biologics license application (BLA), STN BL 125163. Please use the following designators to label prominently all submissions, including supplements, relating to these postmarketing study commitments as appropriate:
 
  • Postmarketing Study Commitment Protocol
  • Postmarketing Study Correspondence
  • Postmarketing Study Commitment – Final Study Report
  • Supplement Contains Postmarketing Study Commitments – Final Study Report

     
For each postmarketing study subject to the reporting requirements of 21 CFR 601.70, you must describe the status in an annual report on postmarketing studies for this product.  Label your annual report as “Annual Status Report of Postmarketing Study Commitments.” The status report for each study should include:
 
  • information to identify and describe the postmarketing commitment,
  • the original schedule for the commitment,
  • the status of the commitment (i.e., pending, ongoing, delayed, terminated, or submitted), and
  • an explanation of the status including, for clinical studies, the patient accrual rate (i.e., number enrolled to date and the total planned enrollment).
 
As described in 21 CFR 601.70(e), we may publicly disclose information regarding these postmarketing studies on our Web site (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm). Please refer to the February 2006 Guidance for Industry: Reports on the Status of Postmarketing Studies – Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (see http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation
/Guidances/UCM080569.pdf
) for further information. 
 
When you have fulfilled your commitment, please label your final report submission as “PMC Submission – Final Study Report or Supplement Contains Postmarketing Study Commitment – Final Study Report.”
 
We will include information contained in the above-referenced supplement in your biologics license application file.
 
Sincerely yours,
 
Wellington Sun, M.D.
Director
Division of Vaccines and
 Related Products Applications
Office of Vaccines
 Research and Review
Center for Biologics
 Evaluation and Research
 
 
Attachment: Approved Final Draft Labeling