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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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,

/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