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March 18, 2010 Approval Letter - Menveo

March 18, 2010

Novartis Vaccines and Diagnostics, Inc.
Attention: Christopher Webster, Ph.D.
350 Massachusetts Avenue
Cambridge, MA 02139-4182

Dear Dr. Webster:

We have received your March 1, 2010, labeling supplement to your biologics license application for Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO) to revise the packing carton and vials to reflect the instructions for use, which state that the MenA Lyophilized Conjugate Component should be reconstituted with the MenCYW-135 Liquid Conjugate Component to form MENVEO and that neither component should be used alone. 

This Supplement has been reviewed under STN 125300/5 and is approved effective this date.

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.

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

This information will be included in your License Application File.

Sincerely yours,

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