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Vaccines, Blood & Biologics

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September 14, 2012 Approval Letter - Imovax

DEPARTMENT OF HEALTH & HUMAN SERVICES                                        Public Health Service
 


                                                                                                                                 Food and Drug Administration
                                                                                                                                 Rockville, MD 20852-1448

 

Our STN: BL 103931/5176                
 
Sanofi Pasteur
Attention: Joseph H Quinn
Discovery Drive
Swiftwater, PA 18370
 
Dear Mr. Quinn:
 
We have approved your request to supplement your biologics license application for Rabies Vaccine, Imovax®, to revise the label to include adverse reaction data from post-marketing experience in the Adverse Reactions section, additional text to ensure clear and complete instructions in the Dosage and Administration section, a clear statement of indications for vaccination in the Indications and Usage section, and modifications of text throughout the package insert to better align with more current recommendations.
 
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 and FDA Form 2567 as appropriate.
 
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 these changes.
 
We will include information contained in the above-referenced supplement in your biologics license application file.
 
Sincerely yours,
 
 /s/
 
Wellington Sun, M.D.
Director
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research