DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Our STN: 25462/0
Attention: Mr. Terry Kraynyk
155 Innovation Drive
Winnipeg, Manitoba R3T 5Y3
Dear Mr. Kraynyk:
We have reviewed your submission dated September 20, 2012 to your biologics license application (BLA) for Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) (Equine) 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, H-BAT, is unacceptable. Your alternatively proposed proprietary name, BAT, is acceptable at this time.
We will perform another proprietary name review of BAT closer to the time of the action due date to ensure that we have not approved a conflicting proprietary name for another product in the interim.
If you have any questions, please contact Nannette Cagungun at (301) 827-6174.
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research