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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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July 27, 2012 Approval Letter - PENTACEL

 

Our STN: BL 125145/201
 
Sanofi Pasteur Limited                                                          
Attention: Joseph H. Quinn                                                   
1755 Steeles Avenue West
Toronto, Ontario                                                                    
Canada M2R 3T4
 
Dear Mr. Quinn:
 
We have approved your request to supplement your biologics license application for Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) Reconstituted with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Combined with Poliovirus Vaccine Inactivated, PENTACEL®, to include the addition of safety information to the Warnings and Precautions section of the package insert regarding the risk of apnea in premature infants.
 
The review of this product was associated with the following National Clinical Trial (NCT) number: NCT00804284.
 
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 this BLA at the time of use (prior to marketing) and include implementation information on FDA Form 356h and FDA Form 2567 as appropriate.
 
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 information contained in the above-referenced supplement in your biologics license application file.
 
                                                                        Sincerely yours,
 
 
 
                                                                        Wellington Sun, M.D.
                                                                        Division 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