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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Letter - Cervarix




Our STN:  BL 125259/0


GlaxoSmithKline Biologicals

Attention: Mr. Matthew Whitman

2301 Renaissance Boulevard

P.O. Box 61540

King of Prussia, PA 19406-2772


Dear Mr. Whitman:


We have received your March 27, 2009, resubmission to your biologics license application for Human Papillomavirus Vaccine, AS04 Adjuvant-Adsorbed, for active immunization to prevent cervical cancer in females 10 years of age and older, on March 30, 2009.


We consider this a complete, Class 2 response to our action letter.  Therefore, the user fee goal date is September 29, 2009.


If you have any questions, please contact the Regulatory Project Manager, Helen S. Gemignani, at (301) 827-3070.


Sincerely yours,




                                                                        Wellington Sun, M.D.


                                                                        Division of Vaccines and

                                                                          Related Products Applications

                                                                        Office of Vaccines

                                                                          Research and Review

                                                                        Center for Biologics

                                                                          Evaluation and Research