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FDA Approves New Recombinant FVIIa Formulation
 

The U.S. Food and Drug Administration approved a new formulation for NovoSeven RT, Novo Nordisk’s recombinant factor VIIa product. NovoSeven RT, manufactured with sucrose and L-Methionine, can be stored at room temperature--up to 77 degrees Fahrenheit for up to two years.

“Approval of this product for room temperature storage creates greater flexibility in disease management for both patients and physicians,” said Jesse L. Goodman, MD, MPH, director of the FDA’s Center for Biologics Evaluation and Research. “As with all FDA-approved products, the agency will monitor NovoSeven RT throughout its life cycle.” The new formulation will primarily help healthcare facilities with limited refrigerated storage space.

NovoSeven RT has the same indications as its predecessor, NovoSeven®, including the treatment of bleeding and the prevention of surgical bleeding in patients with hemophilia A or B and an inhibitor. In addition, it can be used for the treatment of bleeding and the prevention of surgical bleeding in patients with congenital factor VII deficiency and the prevention of surgical bleeding in patients with acquired hemophilia.

Side effects of NovoSeven RT include fever, bleeding, local reaction at the injection site, joint discomfort and headache. Some older patients experienced an increased risk of arterial clotting when the product was used outside of its approved indications.

Source: FDA news release dated May 9, 2008