
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