Vaccines, Blood & Biologics
Our STN: BL 103930/5165
Sanofi Pasteur, Inc.
Attention: Joseph H. Quinn
Swiftwater, PA 18370-0187
Dear Mr. Quinn:
We have approved your request to supplement your biologics license application (BLA) for Poliovirus Vaccine Inactivated (Monkey Kidney Cell),IPOL® to revise the package insert to include, the removal of in vivo chicken potency testing text in the Description section; addition of a latex-free statement in the Description section; addition of a post-marketing subsection to the Adverse Reactions section in order to harmonize post-marketing events with the company core data sheet; updated text in the Dosage and Administration section in order to ensure clarity with regard to administration of the vaccine; and other editorial changes.
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 these changes.
We will include the information contained in the above referenced supplement in your BLA file.
Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research