Major Amendment letter - Flublok
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
Rockville, MD 20852-1448
Our STN: BL 125285/0
Protein Sciences Corporation
Attention: Drs Manon M. J. Cox, MBA
1000 Research Parkway
Meriden, CT 06450-7159
Dear Drs Cox:
We received your August 24, 2009, amendment to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act (42 U.S.C. 262) for Influenza Vaccine on August 25, 2009.
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 January 27, 2010.
If you have any questions, please contact Regulatory Project Manager, Captain Katherine Matrakas, at (301)-827-3070.
Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research