
Class 2 Action Letter - Flublok




 

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