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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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March 15, 2013 Approval Letter - RECOTHROM

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

 

 

Our STN: BL 125248/370                                   
 
ZymoGenetics, Inc.
Attention: Ms. Angela Glauberzon
Bristol Myers Squibb Company
P.O. Box 4000, Mail Stop D22-06
Princeton, NJ 08543-4000
 
Dear Ms. Glauberzon:
 
We have approved your request to supplement your biologics license application for Thrombin topical (Recombinant), to include the safety information from two Phase 4 postmarketing requirement studies and a pediatric indication for use of RECOTHROM in children ages 1 month to 16 years.
 
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 these changes.
 
This product is appropriately labeled for use in ages 1 month to 16 years for this indication. Therefore, no additional studies are needed in this pediatric group.
 
We note that you have fulfilled the pediatric study requirement for ages 1 month to 16 years for this application.
 
We will include information contained in the above-referenced supplement in your biologics license application file.
 
Sincerely yours,
 
 /s/
 
Basil Golding, MD
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics
 Evaluation and Research
 
  
Enclosure