Drug news
FDA accepts filing and grants priority review for defibrotide for treatment of hepatic veno-occlusive disease- Jazz Pharma
Jazz Pharmaceuticals plc announced that FDA has accepted for filing with Priority Review its recently submitted New Drug Application (NDA) for defibrotide. Defibrotide is an investigational agent proposed for the treatment of patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with evidence of multi-organ dysfunction (MOD) following hematopoietic stem-cell transplantation (HSCT).
Defibrotide was approved in the EU as Defitelio in October 2013.
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