Acknowledgment of Filing Letter - Flublok

Our STN: BL 125285/0

 

Protein Sciences Corporation

Attention: Drs Manon M. J. Cox

1000 Research Parkway

Meriden, CT 06450-7159

 

Dear Drs Cox:

 

This letter is in regard to your biologics license application (BLA) for Influenza Vaccine, (FluBlokŪ), for the active immunization of adults 18 years of age and older against influenza disease, submitted under section 351 of the Public Health Service Act.

 

We have completed an initial review of your application dated April 17, 2008, for your Influenza Vaccine to determine its acceptability for filing. Under 21 CFR 601.2(a), we have filed your application today. The review goal date is October 18, 2008. This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted. 


We will contact you regarding your proposed labeling and if post marketing study commitments (506B) are required, no later than September 19, 2008.

 

At this time, we have not identified any potential review issues for inclusion in this letter. Our filing review is only a preliminary review, and deficiencies may be identified during substantive review of your application. Following a review of the application, we shall advise you in writing of any action we have taken and request additional information if needed.

 

If you have any questions regarding this letter, please contact the Regulatory Project Officer,

Captain Katherine Matrakas at (301) 827-3070.

 

Sincerely yours,

 

 /s/

 

Loris D. McVittie, Ph.D.

Acting Director

Division of Vaccines and

   Related Products Applications

Office of Vaccines

 Research and Review

Center for Biologics

 Evaluation and Research