October 15, 2009 Approval Letter - Engerix-B
October 15, 2009
OUR STN: BL 103239/5269
Attention: Byron Bravo
2301 Renaissance Boulevard
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
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.
Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research
Attachment: Approved Draft Labeling