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Vaccines, Blood & Biologics

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January 29, 2010 Approval Letter - Tisseel

Our STN:   BL 103980/5487                    

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 (Tisseel) to include class labeling changes to the package insert and a companion Dear Healthcare Provider letter to address the class labeling changes.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h and FDA Form 2567 as appropriate.  Please provide content of labeling in Structured Product Labeling format. 

In addition, you may wish to submit two draft copies of the proposed introductory advertising and promotional labeling for advisory comment with Form FDA 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, Rockville, MD 20852-1448. 

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)].

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