Acknowledgement Letter - Cervarix, May 24, 2007
Our STN: BL 125259/0
Attention: Sharon W. Shapowal, R.Ph.
2301 Renaissance Bonlevard
P.O. Box 61540
King of Prussia, PA 19406-2772
Dear Ms. Shapowal:
This letter is in regard to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act.
We have completed an initial review of your application dated March 29, 2007, for Human Papillomavirus Bivalent (Types 16, 18) Vaccine, Recombinant, to determine its acceptability for filing. Under 21 CPR 601.2(a) we have filed your application today. The review goal date is January 28,2008. 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.
At this time, we have not identified any potential review issues. 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, please contact the Regulatory Project Manager, Helen S. Gemignani, at (301) 827-3070.
Paul G. Richman, Ph.D.
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research