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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Filing Letter - EVARREST

Our STN:  BL 125392/0

OMRIX Biopharmaceuticals, Ltd.

Attention:  --b(4)---------------

--b(4)--------------

---b(4)---------------

 

Dear –b(4)---------

This letter is in regard to your biologics license application (BLA) submitted under section 351 of the Public Health Service Act.

We have completed an initial review of your application dated November 15, 2010 for Fibrin Pad to determine its acceptability for filing.  Under 21 CFR 601.2(a) we have filed your application today.  The review goal date is September 19, 2011.  This acknowledgment of filing does not mean that we have issued a license nor does it represent any evaluation of the adequacy of the data submitted. 

We will contact you regarding your proposed labeling no later than August 20, 2011.  If postmarketing study commitments (506B) are required, we will contact you no later than August 20, 2011.

While conducting our filing review, we identified potential review issue and will be communicating them to you on or before February 2011.

If you have any questions, please contact the Regulatory Project Manager, Sonday Kelly, at (301) 827-6122.

Sincerely yours,

Dr. Richard Davey, M.D.
Director
Division of Blood Applications
Office of Blood Research and Review  
Center for Biologics
Evaluation and Research