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January 25, 2013 Approval Letter - Prevnar 13
Our STN: BL 125324/767
Wyeth Pharmaceuticals Inc.
Attention: Susan Sciotto-Brown
401 N Middletown Rd
Pearl River, NY 10965
Dear Ms. Sciotto-Brown:
We have approved your request to supplement your biologics license application for Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) to include the prevention of invasive pneumococcal disease in children 6 years through 17 years of age caused by serotypes contained in the vaccine.
The review of this product was associated with the following National Clinical Trial (NCT) number(s): NCT00761631.
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. Please also incorporate the labeling changes approved on January 22, 2013 under STN 125324/442 in the final content of labeling for STN 125324/767.
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of administration are required to contain an assessment of the safety and effectiveness of the product for the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable.
We note that you have fulfilled the pediatric study requirement for the relevant pediatric age groups for this application as described in the original approval letter dated February 24, 2010 as Commitment Number 1: “Deferred pediatric study (6096A-3011) under PREA to evaluate the safety and immunogenicity of Prevnar 13™ in pediatric patients 6 through 16 years of age.”
We will include information contained in the above-referenced supplement in your biologics license application file.
Wellington Sun, M.D.
Division of Vaccines and
Related Products Applications
Office of Vaccines
Research and Review
Center for Biologics
Evaluation and Research