January 25, 2011 Approval Letter - Prevnar 13
Our STN: BL 125324/89
Wyeth Pharmaceuticals Inc.
Attention: Carmel Devlin
401 North Middletown Rd
Pearl River, NY 10965
Dear Ms. Devlin:
We have approved your request to supplement your biologics license application for Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) to revise the package insert. The changes incorporated in the revised package insert include the addition of a statement that recommends a minimal interval between administration of a fourth dose of Prevnar and a catch-up Prevnar 13 dose to Section 2.5, moving the listing of a single hypotonic-hyporesponsive episode, which occurred in a Prevnar 13 clinical trial, from Section 6.2 to Section 6.1, adding language with information about a Prevnar 13 clinical trial, in which four listed events occurred, to Section 6.1, and other minor revisions.
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/
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 include these changes.
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