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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.
Division of Vaccines and
Related Product Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research