
Major Amendment 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 received your August 24, 2009, amendment to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act (42 U.S.C. 262) for Influenza Vaccine on August 25, 2009.

 

We consider your submission a major amendment under the reauthorization of the prescription drug user fee program in the Food and Drug Administration Amendments Act of 2007.

 

Because we received this major amendment within three months of the action due date, we will add an additional three months to the time by which we should complete our review. Therefore, the action due date is January 27, 2010.

 

If you have any questions, please contact 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