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Vaccines, Blood & Biologics

Acknowledgment of Filing Letter - 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: 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, (FluBlok®), 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,
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


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