• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

Proprietary Name Review Letter - BAT

DEPARTMENT OF HEALTH & HUMAN SERVICES                                                     Public Health Service
 


                                                                                                                            Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448

Our STN:  25462/0                                                                        

Cangene Corporation
Attention:  Mr. Terry Kraynyk
155 Innovation Drive
Winnipeg, Manitoba R3T 5Y3
Canada

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.

Sincerely yours,

 

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