BioCentury
ARTICLE | Clinical News

Kangio bivalirudin regulatory update

March 21, 2016 7:00 AM UTC

FDA issued a complete response letter to Eagle for an NDA for anticoagulant Kangio bivalirudin, a ready-to-use formulation of Angiomax bivalirudin from The Medicines Co. (NASDAQ:MDCO, Parsippany, N.J). The agency is requesting “further characterization of bivalirudin-related substances in the drug product,” according to Eagle. ...