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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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RAC Letter - MebHibrix


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:
We have received your April 15, 2011, resubmission to your biologics license application for Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine, for 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 on April 15, 2011.
We consider this a complete, Class 2 response to our action letter. Therefore, the user fee goal date is October 15, 2011.
If you have any questions, please contact the Regulatory Project Manager, CDR David Staten, at (301) 796-2640.
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