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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Filing Letter - Menveo

Our STN:  BL 125300/0

Novartis Vaccines and Diagnostics, Inc.
Attention:  Chris Webster, Ph D
350 Massachusetts Ave
Cambridge, MA, 02139

Dear Dr. Webster:

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 August 29, 2008, for Meningococcus ACWY Conjugate Vaccine (Menveo®), to determine its acceptability for filing.  Under 21 CFR 601.2(a), we have filed your application today.  The review goal date is June 29, 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.

While conducting our filing review, we identified potential review issues and will be communicating them to you on or before November 11, 2008.

We will contact you regarding your proposed labeling no later than May 29, 2009.  If post marketing study commitments (506B) are required, we will contact you no later than May 29, 2009.

If you have any questions, please contact the primary reviewer, Cara Fiore, PhD, at (301) 827-3070.

Sincerely yours,

--signature--

Wellington Sun, MD
Director
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research