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Vaccines, Blood & Biologics

October 8, 2010 Approval Letter - Agriflu

Our STN:  BL 125297/4                         

Novartis Vaccines & Diagnostics, Inc.
Attention:  Ms. Joanne Totosy de Zepetnek
350 Massachusetts Avenue
Cambridge, MA  02139

Dear Ms. Totosy de Zepetnek:

We have received your August 6, 2010, supplement to your biologics license application for Influenza Vaccine, Agriflu®, to revise the Package Insert to include the appropriate warnings regarding natural rubber latex containing components in the tip caps of the pre-filled syringes.

Your submission is in the form of a "Special Labeling Supplement – Changes Being Effected" as described under 21 CFR 601.12(f)(2).

This Supplement has been reviewed under STN 125297/4 and is approved effective this date.

Please submit all final printed labeling at the time of use and include implementation information on Forms FDA 356h.  Provide content of labeling in Structured Product Labeling format.

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 to support that claim.

We will include information contained in the above-referenced supplement in your Biologics License Application file.

Sincerely yours,

Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review  
Center for Biologics Evaluation and Research

Attachment: Approved Final Draft Labeling

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