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New formula for coagulation therapy receives FDA approval
The new formulation provides convenience for facilities with little refrigerated space.
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A new, more convenient form of genetically engineered coagulation Factor VIIa received approval from the FDA last week.
NovoSeven RT (coagulation Factor VIIa recombinant, Novo Nordisk) is a novel formulation of the original bypassing agent, NovoSeven (coagulation Factor VIIa, Novo Nordisk). The original formula was storable at temperatures between 36° F and 46° F for up to three years. The new product contains sucrose and L-Methionine, which gives the formula a shorter shelf life of two years, but allows for storing at temperatures as high as 77 ° F.
“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, in a May 9 press release.
The new formulation is approved for the same uses as the earlier product. The most common adverse events include fever, bleeding, reaction at the injection site and joint discomfort, among others. Increased risk for arterial clotting was observed in some elderly patients when the new formulation was used outside of its approved indications. – by Stacey L. Adams