Proprietary Name Review Letter - Wilate, November 9, 2009

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.

Sincerely yours,

 

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