Learning Center
New In Coagulation
Wednesday, June 4, 2008
FDA Approves New Formulation of Coagulation Therapy
NovoSeven RT Can Be Stored at Room Temperature
The U.S. Food and Drug Administration today approved a new formulation of the genetically engineered version of Factor VIIa, a plasma protein essential for the clotting of blood. The new formulation allows the product to 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, M.D., M.P.H., 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."
NovoSeven RT-the new formulation of NovoSeven Coagulation Factor VIIa (Recombinant)-contains sucrose and L-Methionine, which allow for storage at room temperature. This is helpful for health-care facilities with limited refrigerated space. The original formula could be stored for three years at temperatures between 36 and 46 degrees Fahrenheit.
NovoSeven RT and NovoSeven Coagulation Factor VIIa (Recombinant) are manufactured by Novo Nordisk A/S, located in Denmark.
Donna Castellone
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