Salix, Pharming Group Say FDA Extends PDUFA Action Date For Ruconest

(RTTNews) - Salix Pharmaceuticals, Ltd. (SLXP) and Pharming Group NV (PHARM) Monday announced that the Food and Drug Administration has extended the Prescription Drug User Fee Act, or PDUFA, action date to July 16, 2014 for Biologics License Application for the investigational drug Ruconest, or recombinant human C1 esterase inhibitor, 50 IU/kg.

The companies are seeking U.S. marketing approval of Ruconest for treatment of acute angioedema attacks in patients with hereditary angioedema. Salix Pharma is a pharmaceutical products and medical devices company. Pharming Group develops innovative products for treatment of unmet medical needs.