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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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May 5, 2010 Approval Letter - Engerix-B

May 5, 2010

Our STN:  BL 103239/5276

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

Dear Ms. Valinski:

We have approved your request to supplement your biologics license application for Hepatitis B Vaccine (Recombinant), Engerix-B®, to update the Prescribing Information to include the addition of new adverse events and a warning regarding apnea in premature infants. 

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. 

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 or substantial clinical experience to support such claims [21 CFR 202.1(e)(6)].

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