Our STN:BL 125254/440
CSL Behring LLC
Attention: Paula Hines, Ph.D.
1020 First Avenue
King of Prussia, PA 10406-0901
Dear Dr. Hines:
We have approved your request to supplement your biologics license application for Influenza Virus Vaccine, Afluria®, to revise the package insert.Under this approval, we are approving the following changes to the package insert:
- Include “cellulitis” and “large injection site swelling” in Section 6.2 of the package insert, “Postmarketing Experience”, under the heading of “General disorders and administration site conditions”.
- Revise Section 7.1 of the package insert, “Concurrent Use With Other Vaccines”, to include clarification for using separate syringes and arms when administering Afluria® at the same time as other injectable vaccines.
Please provide your final content of labeling in Structured Product Labeling (SPL) format and include the carton and container labels.All final labelingshould be submitted as Product Correspondence to this BLAat 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.
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 Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research