Our STN: 125430/0
Attention: Mr. Terry Kraynyk
155 Innovation Drive
Winnipeg, Manitoba R3T 5Y3
Dear Mr. Kraynyk:
We have reviewed your submission to your biologics license application (BLA) for Varicella Zoster Immune Globulin (Human), dated June 29, 2012, 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, VARIZIG, is acceptable at this time. Please note that the Agency determines when to utilize tallman lettering and reserves tallman lettering to create a distinction in a proprietary name for the reduction of medication errors when appropriate. APLB does not recommend the use of tallman lettering in this case, and will refer to the name as VARIZIG or Varizig.
We will perform another proprietary name review of VARIZIG 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