
Resubmission Acknowledgment Letter, July 30, 2012 - Flublok

 
 

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