March 8, 2013 Approval Letter -CERVARIX
Our STN: BL 103907/5566 & 125259/249
2301 Renaissance Blvd.
King of Prussia, PA 19406-2772
Dear Ms. Boyce:
We have approved your request to supplements of your biologics license applications for DTaP & Hepatitis B (Recombinant) & Inactivated Polio Virus Vaccine, PEDIARIX® and Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant, CERVARIX®, to include changes to the package insert reflect the discontinuation of the vial presentations.
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 these BLAs 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) for each product 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 these BLAs 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 files.
Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research