Our STN: 125351/0
Nycomed Danmark ApS
Attention: Ms. Camilla Wamberg
Dear Ms. Wamberg:
We have reviewed your June 26, 2009, submission to your biologics license application (BLA) for Fibrin Sealant requesting a proprietary name review.
In consultation with CBER's Advertising and Promotional Labeling Branch (APLB), we have considered your proposed proprietary name TachoSil and conclude that under 21 CFR Part 201 the proposed proprietary name is acceptable at this time.
We will perform another proprietary name review of TachoSil 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 the Regulatory Project Manager, Jie He, at (301) 827-9167.
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research