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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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July 28, 2010 Approval Letter - Fluvirin

Our STN: BL 103837/5543

Novartis Vaccines and Diagnostics Limited
Attention: Dr. Joanne Totosy de Zepetnek, PhD
350 Massachusetts Avenue
Cambridge, MA 02139

Dear Dr. Totosy de Zepetnek:

We have approved your request to supplement your Biologics License Application for Influenza Virus Vaccine, Fluvirin®, to include the 2010-2011 United States formulation.

We acknowledge your commitment made during the July 19, 2010, telephone conversation between Dr. Hillel Cohen of Novartis and Ms. Darlene Hithe of this office that the agreed upon Dear Health Care Provider letter, received on July 23, 2010, as an amendment to this supplement, which explains discrepancies in your labeling regarding latex statements will be included in shipping containers of the pre-filled syringe cartons of Fluvirin®. We also acknowledge your commitment to submit a CBE supplement using the preassigned STN of 103837/5549 for a revised version of the Fluvirin® Package Insert that includes the information on the possible presence of natural rubber latex in the tip caps for the pre-filled syringes.

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

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

Sincerely yours,

/signature/

Jerry P. Weir, Ph.D.
Director
Division of Viral Products
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research
Attachment: Approved Final Draft Labeling