FDA OKs New Coagulation Formulation
Posted on: Monday, 12 May 2008, 12:00 CDT
The U.S. Food and Drug Administration announced approval of a new formulation of the genetically engineered version of Factor VIIa, a coagulation therapy.
The FDA said the new formulation of the plasma protein that's essential for the blood-clotting allows the product to be stored at room temperature -- up to 81 degrees Fahrenheit -- for as long as two years.
NovoSeven RT -- the new formulation of NovoSeven Coagulation Factor VIIa (Recombinant) -- contains sucrose and L-Methionine, which allows storage at room temperature. The FDA said that is helpful for healthcare facilities with limited refrigerated space. The original formula could be stored for three years at temperatures between 36 and 46 degrees.
NovoSeven RT is indicated for treatment of bleeding and the prevention of surgical bleeding in patients with hemophilia A or B, who have antibodies that neutralize the action of clotting Factors VIII or IX.
NovoSeven RT and NovoSeven Coagulation Factor VIIa are manufactured by Novo Nordisk in Denmark.
Source: United Press International
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