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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Response to August 21, 2009 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:

We have received your August 21, 2009, resubmission to your biologics license application for Meningococcal Polysaccharide (Serogroups A, C, Y, W-135) CRM197 Conjugate Vaccine, for the active immunization of individuals 11-55 years of age, for the prevention of disease caused by N. meningitis serogroups A/C/Y/W-135 on August 21, 2009.

We consider this a complete, Class 2 response to our action letter. Therefore, the user fee goal date is February 20, 2010.

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

Sincerely yours

Wellington Sun, M.D.


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


Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002