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Tuesday, February 19, 2019

Novo Nordisk announces FDA approval of ESPEROCT

Novo Nordisk announced that the U.S. Food and Drug Administration has approved the Biologics License Application for ESPEROCT for the treatment of adults and children with haemophilia A. ESPEROCT is the brand name for turoctocog alfa pegol, N8-GP. ESPEROCT is indicated for use in adults and children with haemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes and perioperative management of bleeding. Due to third-party IP agreements, Novo Nordisk will not be able to launch ESPEROCT before 2020 in the USA, the company noted.

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