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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Proprietary Name Memorandum - EVARREST

Our STN: 125392/0/1

OMRIX biopharmaceuticals, Ltd.

Attention: ---b(4)-------------

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

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

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


Dear –b(4)---------:

We have reviewed your submission dated January 10, 2011 to your biologics license application (BLA) for Fibrin Pad requesting a proprietary name review.

In consultation with CBER’s Advertising and Promotional Labeling Branch (APLB) we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable regulations, your proposed proprietary name, EVARREST, is acceptable at this time.

We will perform another proprietary name review of EVARREST closer to the time of the action due date to ensure that FDA has not approved a conflicting proprietary name for another product in the interim.

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

Sincerely yours,

 

Basil Golding, M.D.
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research