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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

NDI Letter - Agriflu

Our STN: BL 125297/0

Novartis Vaccines and Diagnostics Inc.,
Attention: Joanne Totosy de Zepetnek, PhD
Associate Director, Vaccines Regulatory Affairs
350 Massachusetts Ave
Cambridge, MA, 02139

Dear Dr. Totosy de Zepetnek:

This letter is in regard to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act.

We have completed an initial review of your application dated July 10, 2008, for Influenza Vaccine (AgrippalĀ®), to determine its acceptability for filing.  Under 21 CFR 601.2(a), we have filed your application today.  The review goal date is May 11, 2009.  This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted.

We will contact you regarding your proposed labeling no later than April 11, 2009.  If post marketing study commitments (506B) are required, we will contact you no later than April 11, 2009.

At this time, we have not identified any potential review issues for inclusion in this letter.  Our filing review is only a preliminary review, and deficiencies may be identified during substantive review of your application.  Following a review of the application, we shall advise you in writing of any action we have taken and request additional information if needed.

If you have any questions, please contact the Regulatory Project Manager, Dr. Bernard McWatters, at (301) 827-3070.

Sincerely yours,

Wellington Sun, MD
Director

Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review
Center for Biologics Evaluation and Research