Novo Nordisk NovoSeven new trial will be conducted prior to U.S. marketing; antidiabetic Prandin pending.
Executive Summary
NOVO NORDISK NOVOSEVEN LAUNCH PROJECTED FOR FIRST HALF 1998 following initiation of another clinical trial of the blood clotting agent, the company said in its Aug. 13 quarterly sales and earnings report. Novo Nordisk filed a BLA for the recombinant activated coagulation Factor VIIa in June 1996 for treatment of hemophiliacs with inhibitors (antibodies) to Factor VIII or Factor IX. In September 1996, FDA's Blood Products Advisory Committee, while expressing support for NovoSeven, agreed with FDA that further study of NovoSeven is warranted.
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