August 16, 2013 Approval Letter - FluLaval
Our STN: BL 125163/254
ID Biomedical Corporation of Quebec
dba GlaxoSmithKline Biologicals
Attention: Judith A. Magner
2301 Renaissance Blvd., Building 510
King of Prussia, PA 19406
Dear Ms. Magner:
We have approved your request to supplement your biologics license application for Influenza Virus Vaccine (FluLaval®) manufactured at your Sainte-Foy, Quebec, Canada facility, to include use in persons 3 years to 17 years of age for the prevention of influenza disease caused by influenza viruses contained in the vaccine.
Approval of this supplement fulfills requirements 1 and 2 in our letter of June 1, 2011, which was a clarification of the October 5, 2006, approval letter as follows: 1) To conduct a safety and immunogenicity study of your Influenza Virus Vaccine in children 3 to 17 years of age; and 2) To conduct a clinical endpoint efficacy study of your Influenza Virus Vaccine in children 3 to 8 years of age.
The review of this product was associated with the following National Clinical Trial (NCT) number: NCT00980005.
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 biologics license application at the time of use (prior to marketing) and include implementation information on FDA Form 356h.
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 biologics license application that include revised labeling incorporating a revised content of labeling that includes these changes.
Postmarketing Studies Subject to Reporting Requirements of 21 CFR 601.70
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable.
We are waiving the pediatric study requirement in infants from 0 to < 6 months of age, because this product does not represent a meaningful therapeutic benefit over existing therapies for pediatric patients and is not likely to be used in a substantial number of infants < 6 months of age. Available data indicate that serum antibody responses to inactivated influenza vaccines in infants < 6 months of age are not as robust as in older children due to inherent immaturity of the immune system and interference from maternal antibody.
We are deferring submission of your pediatric study for 6 months to 35 months of age for this application because this product is ready for approval for use in persons 3 years of age and older and the pediatric study in younger children has not been initiated.
Your deferred pediatric study required under 505B(a) of the Federal Food, Drug, and Cosmetic Act is a required postmarketing study. The status of this postmarketing study must be reported according to 21 CFR 601.70 and section 505B(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act. This required study and timeline described in your letter of August 14, 2013, are outlined below:
Deferred pediatric study under PREA to evaluate the safety and immunogenicity of FluLaval® Quadrivalent in children 6 to 35 months of age.
Final Protocol Submission Date: June 30, 2014
Study Completion Date: September 30, 2015
Final Report Submission: March 31, 2016
This product is appropriately labeled for use in persons 3 years of age and older. Therefore, no additional studies are needed in the pediatric group 3 to 17 years of age.
Please submit clinical protocols to your IND, and a cross-reference letter to your biologics license application, STN BL 125163. Submit nonclinical and chemistry, manufacturing, and controls protocols and all final study reports to your biologics license application, STN BL 125163. If the information in the final study report supports a change in the labeling, the final study report should be submitted as a supplement. We may also request a supplement, if we determine that labeling changes are necessary. 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 an “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).
When you have fulfilled your commitment, submit your final report as a 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.
Wellington Sun, MD
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research
Attachment: Approved Final Draft Labeling