Proprietary Name Accepted - Wilate, July 24, 2007
Our STN: BL 125251/0
Octapharma Pharmazeutika Produktionsges. m.b.H
Attention: Barbara Rangetiner, Ph.D.
Oberlaaer Strasse 235
Dear Dr. Rangetiner:
This letter is in regard to your proposed proprietary names for Von Willebrand Factor Concentrate (Human), “WILATE” and “WILNATIV”, received on May 10, 2007.
We have considered your proposed proprietary names, "WILATE" and "WILNATIV" in consultation with CBER's Advertising and Promotional Labeling Branch (APLB) and conclude that under 21 CFR Part 201, the proposed proprietary name WILATE is acceptable and WILNATIV is not acceptable.
If you have any questions, please contact Mr. Franklin T. Stephenson, at (301) 827-3524.
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research