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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Filing NDI Letter, MenHibrix

Our STN:  BL 125363/0

GlaxoSmithKline Biologicals

Attention:  Jody Gould, Ph.D.

2301 Renaissance Blvd.
P.O. Box 61540
King of Prussia, PA 19406

Dear Dr. Gould:

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 12, 2009 for Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine to determine its acceptability for filing.  Under 21 CFR 601.2(a) we have filed your application today.  The review goal date is June 11, 2010.  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 May 14, 2010.  If post marketing study commitments (506B) are required, we will contact you no later than May 14, 2010.

At this time, we have not identified any potential review issues.  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, LCDR Jason Humbert, at (301) 827-3070.

Sincerely yours,

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