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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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August 29, 2011 Approval Letter - ARTISS

Our STN:  BL 125266/194                                  

 
Baxter Healthcare Corporation
Attention: Gretchen Murray, Ph.D.
One Baxter Way
Westlake Village, CA  91362
 
Dear Dr. Murray:
 
We have approved your request to supplement your biologics license application for Fibrin Sealant (Human) to extend the indication to adhere tissue flaps during facial rhytidectomy surgery (face-lift).
 
The review of this product was associated with the following National Clinical Trial (NCT) numbers: NCT00708071 and NCT00999141.
 
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.
 
We are waiving the pediatric study requirement for this application because necessary studies are impossible or highly impracticable since rhytidectomy is an adult procedure and not performed in the pediatric population.
 
We will include information contained in the above-referenced supplement in your biologics license application file.
 
                                                                        Sincerely yours,
 
 
 
                                                                        Basil Golding, M.D.
                                                                        Director
                                                                        Division of Hematology
                                                                        Office of Blood Research and Review  
                                                                        Center for Biologics
                                                                         Evaluation and Research