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April 1, 2011 Approval Letter-Menveo

Our STN: BL STN 125300/7 and 125300/49

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

Dear Dr. Webster:

We have approved your requests to supplement your biologics license application (BLA) for Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®) to include the re-evaluated immunogenicity data due to a transcription error that lead to the revision of V59P13 and V59P18 immunogenicity data in the original submission (125300/7) and data regarding the persistence of meningococcal antibodies in adolescents through 21 months following the first vaccination with MENVEO (125300/49).  The changes from each of these supplements have been incorporated into a single revised package insert as referenced below.

We acknowledge that you intend to submit corrected tables as product correspondence under STN 125300/223, incorporating the revised data into final clinical study reports for protocols V59P13, V59P13E1 and V59P18.  These corrected tables will be submitted as addenda to the final study reports by August 30, 2011.

The review of this product was associated with the following National Clinical Trial (NCT) number(s): NCT00262002, NCT00310817, NCT00262041, NCT00329901, NCT00450437, and NCT00856297.

Please provide your final content of labeling in Structured Product Labeling (SPL) format and include the carton and container labels.  In addition, please submit three original paper copies for carton and container final printed labeling.  All final labeling should be submitted as Product Correspondence to this BLA at the time of use (prior to marketing) and include implementation information on FDA Form 356h.

In addition, please submit the final content of labeling (21 CFR 601.14) in SPL format via the FDA automated drug registration and listing system, eLIST, as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.  Information on submitting SPL files using eLIST may be found in the guidance for industry titled, “SPL Standard for Content of Labeling Technical Qs and As” at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation

You may submit two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. You must submit copies of your final advertisement and promotional labeling at the time of initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR 601.12(f)(4)).

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 or substantial clinical experience to support such claims (21 CFR 202.1(e)(6)).

Please submit an amendment to all pending supplemental applications for this BLA that include revised labeling incorporating a revised content of labeling that includes these changes.

We will include information contained in the above-referenced supplements in your biologics license application file. 

Sincerely yours,

Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccine
Research and Review
Center for Biologics               
Evaluation and Research

Attachment: Approved Final Draft Labeling