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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Acknowledgement Letter, August 24, 2009 - MenHibrix

GlaxoSmithKline Biologicals                                                    
Attention: Jody Ann Gould, Ph.D.                                                        
2301 Renaissance Boulevard                                                    August 24, 2009
P.O. Box 61540
King of Prussia, PA  19406-2772

Dear Dr. Gould:

We have received your biologics license application (BLA) submitted under section 351 of the Public Health Service Act for the following biological product:

Our Submission Tracking Number (STN):  BL 125363/0

Biological Product: Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine

Indication:  Active immunization of infants and toddlers 6 weeks through 15 months of age for the prevention of invasive diseases caused by Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y.

Date of Supplement: August 12, 2009

Date of Receipt: August 12, 2009

First Action Due Date: June 12, 2010

US License Number: 1617

We will notify you within 60 days of the receipt date if the application is sufficiently complete to permit a substantive review.

We request that you submit all future correspondence, supporting data, or labeling relating to this application in triplicate, citing the above STN number.  Send all correspondence to the following address:

Norman Baylor, Ph.D., HFM-475
Center for Biologics Evaluation and Research
Food and Drug Administration
Suite 200N
1401 Rockville Pike
Rockville, MD 20852-1448

If you have any questions, please contact LCDR Jason Humbert, Regulatory Project Manager, at (301) 827-3070.

Sincerely yours,

 

Elizabeth M. Sutkowski, Ph.D.
Chief
Regulatory Review Branch 3
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics 
Evaluation and Research