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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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.
 
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