October 15, 2009 Approval Letter - Engerix-B

October 15, 2009

OUR STN:  BL  103239/5269

GlaxoSmithKline Biologicals
Attention: Byron Bravo
2301 Renaissance Boulevard

Building 510
King of Prussia, PA 19406-2772

Dear Mr. Bravo:

We have approved your request to supplement your biologics license application for

Hepatitis B Vaccine (Recombinant), to include the introduction of a 10 pack carton of

Engerix-B 10 mcg Pre-Filled Syringes for Pediatric/Adolescent use, and accompanying

Package Insert.

Please submit all final printed labeling at the time of use and implementation information on Form FDA 356h and FDA form 2567 as appropriate.  Please provide content of labeling in Structured Product Labeling format. 

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

 Sincerely yours,

 

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 Draft Labeling