October 31, 2014 Approval Letter - Fluzone High Dose
Our STN: BL 103914/5726
Sanofi Pasteur Inc.
Attention: Michael F. Stirr
Swiftwater, PA 18370
Dear Mr. Stirr:
We have approved your request to supplement your biologics license application for Influenza Vaccine Fluzone®, to include data from the confirmatory clinical studies to verify and describe the clinical benefit of Fluzone® High Dose formulation.
We licensed Fluzone® High Dose formulation under the accelerated approval regulations with a post marketing requirement (21 CFR 601.41). Approval of this supplement fulfills your commitment to submit the results of the ongoing Study No. FIM12, an active-controlled clinical endpoint efficacy and safety study of Fluzone® High-Dose compared to standard dose Fluzone® in 30,000 adults 65 years of age and older, enrolled over two influenza seasons, as stated in the June 27, 2012, letter (103914/5541).
The review of this product was associated with the following National Clinical Trial (NCT) numbers: NCT00391053 and NCT01427309
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 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/
You may submit two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Advertising and Promotional Labeling Branch at the following address:
Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
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.
We will include information contained in the above-referenced supplement in your biologics license application file.
Wellington Sun, M.D.
Division of Vaccine and
Related Product Application
Office of Vaccines and
Research and Review
Center for Biologics
Evaluation and Research
Attachment: Approved Final Draft Labeling