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Vaccines, Blood & Biologics

June 2, 2010 Approval Letter - Engerix

GlaxoSmithKline Biologicals
Attention: Mr. 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 applications to revise the package insert to include new National Drug Code (NDC) numbers for pre-filled syringes that contain no latex and a statement regarding the availability of pre-filled syringes with and without latex containing components for the following products:

103239/5273 – Hepatitis B Vaccine (Recombinant)
103475/5303 – Hepatitis A Vaccine, Inactivated

Please submit all final printed labeling and implementation information on FDA Form 356h.  Please provide a PDF-format electronic copy.  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 files.

Sincerely yours,

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 Final Draft Labeling

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