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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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September 19, 2011 Approval Letter - IMOVAX

Our STN:   BL 103931/5161                    

 
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, to include revisions to the carton and syringe diluent labels to change from "Sterile Water for Injection" to "Sterile Water, diluent for reconstitution".
 
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,
 
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,
 
 
 
                                                                        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