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September 14, 2012 Approval Letter - Prevnar 13

DEPARTMENT OF HEALTH & HUMAN SERVICES                                        Public Health Service
 


                                                                                                                                 Food and Drug Administration
                                                                                                                                 Rockville, MD 20852-1448

 

Our STN: BL 125324/852                        
 
Wyeth Pharmaceuticals Inc.
Attention: Ms. Melodee Diss                                                   
401 N. Middletown Road
P.O. Box 61540
Pearl River, NY 10965
 
Dear Ms. Diss:
 
We have approved your request to supplement your biologics license application for Pneumococcal 13-valent Conjugate Vaccine (Diptheria CRM197 Protein), Prevnar 13®,to include proposed revisions for the How Supplied/Storage and Handling section of the package insert and for the carton.   These changes include the new presentation for Prevnar 13® as a single prefilled syringe pack to be used in Pfizer Helpful Answers® as well as in the commercial trade. This approval also includes the proposed typographical corrections to Table 22 of the package insert.
 
Please provide your final content of labeling in Structured Product Labeling (SPL). 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.
 
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 Biologics License Application file.
 
 
Sincerely yours,
 
 /s/
 
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