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Novo Nordisk A/S' Novoeight Receives FDA Approval

Tuesday, 15 Oct 2013 08:00pm EDT 

Novo Nordisk A/S announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics License Application (BLA) for recombinant coagulation factor VIII, Novoeight. The FDA approved Novoeight for use in adults and children with haemophilia A for (i) control and prevention of bleeding, (ii) perioperative management, and (iii) routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Awaiting the expiration of existing patents, Novo Nordisk plans to launch Novoeight in the United States shortly after April 2015.