FDA Accepts Santarus’ Marketing Application for Angioedema DrugWednesday, June 19, 2013
San Diego-based Santarus Inc. announced that the U.S. Food and Drug Administration has accepted the marketing application for its drug, Ruconest.
The FDA will complete its review by next April. Santarus applied for market approval with its partner company, Pharming Group NV. Santarus licensed certain exclusive rights from Pharming to commercialize Ruconest in North America. Under the terms of the license agreement, Santarus will pay $5 million to Pharming thanks to FDA application acceptance.
Ruconest treats hereditary angioedema, which is a rapid, dangerous swelling of the skin.
— SDBJ Staff Report