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Salix Pharmaceuticals Ltd announces extension of PDUFA action date for ruconest


Monday, 24 Feb 2014 01:30am EST 

Salix Pharmaceuticals Ltd:Salix and Pharming announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA).Says action Date extended to July 16, 2014 for the company's Biologics License Application (BLA) for the investigational drug RUCONEST (recombinant human C1 esterase inhibitor) 50 IU/kg.Salix and Pharming are seeking U.S. marketing approval of RUCONEST for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE). 

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