Class 2 Action 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 have received your April 27, 2009, resubmission to your biologics license application for Influenza Vaccine, for the active immunization of adults 18 years of age and older against influenza disease on April 28, 2009.
We consider this a complete, Class 2 response to our action letter. Therefore, the user fee goal date is October 28, 2009.
If you have any questions, please contact the 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