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July 22, 2011 Approval Letter - Havrix


Our STN: BL 103475/5343

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 immunogenicity and safety data to support concomitant administration of Havrix with M-M-R®IIand VARIVAX® among children 12-15 months of age. In addition, we have approved your request to include safety data in approximately 3,000 children who received Havrix® in the second year of life. 
 
The review of this product was associated with the following National Clinical Trial (NCT) number: 00197015.
 
We have completed the review of your submission and find that the following postmarketing commitments have been satisfied. The two commitments as stated in the approval letter for STN 103475/5090 for Hepatitis A Vaccine Inactivated, Havrix® addressed in this submission are as follows:
 
1.  You have agreed to evaluate the safety of administrating two doses of Havrix® six months apart in at least 3000 children 12 to 23 months of age.
 
3.  You have agreed to conduct an open, randomized, controlled study to evaluate safety and immunogenicity of concurrent immunization of Havrix® (720 EL. U./0.5 mL dose) with MMR®II and Varivax® in healthy children 12 to 15 months of age. The safety data for children administered two doses of Havrix® in this study may be included as part of your commitment to assess safety in at least 3000 children 12 to 23 months of age.  
 
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. In addition, please submit three original paper copies for carton and container final printed labeling.  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
 
Attachment: Approved Final Draft Labeling