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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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May 5, 2010 Approval Letter - Cervarix

May 5, 2010

Our STN:  BL 125259/18

GlaxoSmithKline Biologicals
Attention: Byron Bravo
2301 Renaissance Boulevard
P.O. Box 61540
King of Prussia, PA  19406-2772

Dear Mr. Bravo:

We have approved your request to supplement your biologics license application for Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant, to request that the pre-filled syringe cartons contain language stating that the tip cap and rubber plunger contain dry natural latex rubber

All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide content of labeling in Structured Product Labeling format. 

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

/signature/

Wellington Sun, M.D.
Director
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research

Attachment: Approved Final Draft Labeling