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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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June 11, 2013 Approval Letter-HAVRIX

 

Our STN:   BL 103475/5442
 
GlaxoSmithKline Biologicals
Attention: Patrick J. Thomas
2301 Renaissance Boulevard
P.O. Box 61540
King of Prussia, PA 19406-2772
 
Dear Mr. Thomas:
 
We have approved your request to supplement your biologics license application for Hepatitis A Vaccine Inactivated, Havrix® to include a revision of the United States prescription information’s (USPI). The revised USPI includes a summary sentence of the safety data related to the 360 EL.U. dose in section 6.1 and added a reference to section 16 (How Supplied/Storage and Handling) in Section 3 (Dosage Forms and Strengths) of the USPI.
 
Under 21 CFR 201.57(c)(18), patient labeling must be reprinted at the end of the package insert. We request that the text of information distributed to patients be printed in a minimum of 10-point font.
 
Please provide your final content of labeling in Structured Product Labeling (SPL) format and include the carton and container labels.  All final labeling should be submitted as Product Correspondence to this BLA at the time of use (prior to marketing) and include implementation information on FDA Form 356h.
 
In addition, please submit the final content of labeling (21 CFR 601.14) in SPL format via the FDA automated drug registration and listing system, (eLIST), as described at http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Information on submitting SPL files using eLIST may be found in the guidance for industry titled, “SPL Standard for Content of Labeling Technical Qs and As at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072392.pdf.
 
You may submit two draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. You must submit copies of your final advertisement and promotional labeling at the time of initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR 601.12(f)(4)).
 
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)).
 
Please submit an amendment to all pending supplemental applications for this BLA that include revised labeling incorporating a revised content of labeling that includes this change(s).
 
We will include information contained in the above-referenced supplement in your biologics license application file.
 
 
Sincerely yours,
 
 
Wellington Sun, M.D.
Director
Division of Vaccines and
 Related Products Applications
Office of Vaccine
 Research and Review
Center for Biologics Evaluation and Research