Nuwig Approved for Treating Bleeding Episodes
September 15, 2015 – The U.S. Food and Drug Administration granted Octapharma USA approval for Nuwiq, a recombinant antihemophilic factor (blood factor VIII), for the immediate treatment and control of bleeding episodes, routine prophylaxis to reduce the frequency of bleeding episodes; and management of bleeding in a surgical setting. Nuwiq is indicated for use in adults and children with Hemophilia A, but not for the treatment of von Willebrand Disease. Hemophilia A affects up to 16,000 individuals in the U.S. Nuwiq is provided as a lyophilized powder for solution for intravenous injection. Dosing depends on a patient’s age and weight, clinical condition, severity of deficiency, and the location and degree of bleeding. Octapharma USA plans on launching Nuwiq by early 2016.
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