Eagle slides after FDA rejects anticoagulant Kangio

Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) sank $10.18 (19%) to $43.50 on Friday after FDA issued a complete response letter for an NDA for anticoagulant Kangio bivalirudin, a ready-to-use formulation of Angiomax bivalirudin from The Medicines Co. (NASDAQ:MDCO).

The company had submitted the NDA under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data from the scientific literature or from other approved products. According to Eagle, FDA "requested further characterization of bivalirudin-related substances in the drug product." ...