Our STN: BL 103665/5442
Novo Nordisk Inc.
Attention: Mary Ann McElligott, Ph.D.
100 College Road West
Princeton, NJ 08540
Dear Dr. McElligott:
We have approved your request to supplement your biologics license application for Coagulation Factor VIIa (Recombinant) to include a Black Box Warning on serious thrombotic adverse events associated with the use of NovoSeven® RT outside labeled indications. In addition, you updated the Warnings and Precautions section to reflect the rate of thrombotic events of possible or probable relationship to NovoSeven® RT in clinical trials within the approved indications.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h and FDA Form 2567 as appropriate. Please provide content of labeling in Structured Product Labeling format.
All promotional claims must be consistent with and not contrary to approved labeling. You should not make a comparative promotional claim or claim of superiority over other products unless you have substantial evidence to support that claim.
We will include information contained in the above-referenced supplement in your biologics license application file.
Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics
Evaluation and Research