
Major Amendment Letter - Q-Pan

 

DEPARTMENT OF HEALTH & HUMAN SERVICES


Public Health Service



Food and Drug Administration
 1401 Rockville Pike
 Rockville, MD 20852-1448

Our STN: BL 125419/0

ID Biomedical Corporation of Quebec
 Attention: Michael Schwartz, Ph.D.
 GlaxoSmithKline Biologicals
 2301 Renaissance Boulevard, P.O. Box 61540
 King or Prussia, PA 19406-2772

Dear Dr. Schwartz:

We received your November 30, 2012, amendment to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act (42 U.S.C. 262) for Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted on February 22, 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 March 23, 2013.

If you have any questions, please contact the Regulatory Project Managers, LCDR Jeremy Wally, Ph.D. or Kirk Prutzman, Ph.D., at (301) 796-2640.

Sincerely yours,

Wellington Sun, M.D.
 Director
 Division of Vaccines and 
 Related Product Applications
 Office of Vaccines 
 Research and Review
 Center for Biologics 
 Evaluation and Research
