Santarus Inc (SNTS)

[surf1944]

2:31AM Santarus and Pharming announce FDA acceptance for review of RUCONEST Biologics License Application (SNTS) 21.52 : Santarus and Pharming Group NV announce that the FDA has accepted for filing the Biologics License Application for the investigational drug RUCONEST 50 IU/kg. Santarus and Pharming are seeking U.S. marketing approval of RUCONEST for the treatment of acute angioedema attacks in patients with hereditary angioedema. The FDA indicated that as part of its review it plans to present the BLA to the Blood Products Advisory Committee. Pursuant to the Prescription Drug User Fee Act guidelines, Santarus and Pharming expect the FDA will complete its review or otherwise respond to the RUCONEST BLA by April 16, 2014.