Our STN: 125251/0
Octapharma Pharmazeutika Produktionsges.m.b.H.
Attention: Mr. Stanley Ammons
Octapharma USA, Inc.
121 River Street, 12th floor
Hoboken, NJ 07030
Dear Mr. Ammons:
We have reviewed your submission dated May 10, 2007, to your biologics license application (BLA) for Coagulation Factor VIII/von Willebrand Factor Complex (Human) 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, Wilate, is acceptable at this time.
If you have any questions, please contact Pauline Cottrell at (301) 827-6162.
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research