Filing Letter - Cervarix, April 9, 2007

April 9, 2007

 GlaxoSmithKline Biologicals
 Attention: Ms. Sharon W. Shapowal
 230 I Renaissance Boulevard
 P.O. Box 61540
 King of Prussia, PA 19406-2772

 Dear Ms. Shapowal:

 We have received your biologics license application (BLA) submitted under section 351 of the Public Health Service Act for the following biological product:
 Our Submission Tracking Number (STN): BL 125259/0
 Biological Product: Human Papillomavirus Vaccine, AS04 Adjuvant-Adsorbed
 Indication: Active immunization to prevent cervical cancer in females 10 years of age and older.
 Date of Supplement: March 29,2007
 Date of Receipt: March 29, 2007
 First Action Due Date: January 28, 2008
 US License: 1617

 Please submit all future correspondence, supporting data, or labeling relating to this application in triplicate, citing the above STN number. Send all correspondence to the following address:

 We will notify you within 60 days of the receipt date if the application is sufficiently
 complete to permit a substantive review.

 Norman Baylor, Ph.D., HFM-475
 Center for Biologics Evaluation and Research
 Food and Drug Administration
 Suite 200N
 1401 Rockville Pike
 Rockville, MD 20852-1448

 

We wil notify you within 60 days of the receipt date if the application is sufficiently complete to permit a substantive review.

 If you have any questions, please contact Ms. Helen Gemignani, Regulatory Project Manager, at (301) 827-3070.
 Sincerely yours,
 Loris D. McVittie, Ph.D.
 Chief
 Viral Vaccine Branch
 Division of Vaccines and
 Related Products Applications
 Offce of Vaccines
 Research and Review
 Center for Biologics
 Evaluation and Research
