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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Major Admendment Letter - MenHibrix

 

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                
Public Health Service 
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
 
Our STN: BLA 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 received your May 9, 2012, amendment to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act (42 U.S.C. 262) for Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine on May 9, 2012.
 
We consider your submission a major amendment under the reauthorization of the prescription drug user fee program in the Food and Drug Administration Amendments Act of 2007.
 
Because we received this major amendment within three months of the action due date, we will add an additional three months to the time by which we should complete our review. Therefore, the action due date is August 31, 2012.
 
If you have any questions, please contact Regulatory Project Manager, Dr. Kirk Prutzman, at (301) 796-2640.
 
Sincerely yours,
 
 /s/
 
Wellington Sun, M.D.
Director
Division of Vaccines and
 Related Products Applications
Office of Vaccines
 Research and Review
Center for Biologics
 Evaluation and Research