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August 24, 2010 Approval Letter - Fluvirin
Our STN: BL 103837/5549
Novartis Vaccines and Diagnostics Limited
Attention: Dr. Joanne Totosy de Zepetnek, Ph.D.
350 Massachusetts Avenue
Cambridge, MA 02139
Dear Dr. Totosy de Zepetnek:
We have received your July 29, 2010, supplement to your biologics license application for Influenza Virus Vaccine, Fluvirin®, 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 103837/5549 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.
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