Our STN: BL 103665/5231
Novo Nordisk Inc.
Attention: Dr. Mary Ann McElligott
100 College Rd West
Princeton, NJ 08540
Dear Dr. McElligott:
We have approved your request to supplement your biologics license application for Coagulation Factor VIIa (Recombinant), for the introduction of a room temperature stable formulation of Coagulation Factor VIIa (Recombinant) (rFVIIa) [NovoSeven®] referred to as VII25.
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels).
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.
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Basil Golding, M.D.
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research