
RAC 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:

 

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,

 

 /s/

 

Wellington Sun, M.D.

Director

Division of Vaccines and

Related Product Applications

Office of Vaccines

Research and Review

Center for Biologics

Evaluation and Research

 