Our STN: BL 103837/5602
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 Vaccine (Fluvirin®) manufactured at your Speke, Liverpool facility in the United Kingdom, to revise Section 6.3, Postmarketing Experience, of the Fluvirin package insert to include information on thrombocytopenia, cellulitis, extensive limb swelling and skin and subcutaneous disorders.
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 include these changes.
We will include the information contained in the above referenced supplement in your Biologics License Application file.
Wellington Sun, M.D.
Division of Vaccine and Related
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research