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October 29, 2010 Approval Letter - Agriflu

Our STN:  BL 125297/1                    

Novartis Vaccines and Diagnostics, Inc.
Attention:  Joanne Totosy de Zepetnek, Ph.D.
Vaccine Regulatory Affairs
350 Massachusetts Avenue
Cambridge, MA 02139-4182

Dear Dr. Totosy de Zepetnek:

We have approved your request to supplement your biologics license application for Influenza Virus Vaccine (Agriflu®), to include data from the confirmatory clinical studies to verify and describe the clinical benefit.

We licensed Agriflu under the accelerated approval regulations with a post marketing requirement (21 CFR 601.41).  We have completed the review of your submission and by approval of this supplement, the following requirement from the November 27, 2009, approval letter has been fulfilled:

  1. Novartis Vaccines and Diagnostics agrees to submit the results of Study No. V58P13, a placebo-controlled clinical endpoint efficacy and safety study of Novartis’s Agriflu® in healthy adults 18 to 49 years of age.  The final study report for the study will be submitted by January 31, 2010.

The review of this product was associated with the following National Clinical Trial (NCT) numbers: NCT00464672, NCT00617851, NCT00630331.

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 your 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 & 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)).

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

/s/ 

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