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Vaccines, Blood & Biologics

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Vaccines

Resubmission Acknowledgment Letter, July 30, 2012 - 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: Penny L. Post, Ph.D.
1000 Research Parkway
Meriden, CT 06450-7159
 
Dear Dr. Post:
 
We have received your July 16, 2012, 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 July 17, 2012.
 
We consider this a complete, Class 2 response to our action letter. Therefore, the user fee goal date is January 16, 2013.
 
If you have any questions, please contact the Regulatory Project Manager, Dr. Timothy Fritz, at (301) 796-2640.
 
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