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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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