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Biotech / Medical : biotech firesales

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From: Julius Wong	3/18/2016 8:48:22 AM
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FDA rejects Eagle Pharma's New Drug Application for anticoagulant IV bivalirudin; shares off 16% premarket Eagle Pharmaceuticals (NASDAQ: EGRX) receives a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) seeking clearance of KANGIO (bivalirudin injection), an intravenous formulation of 5 mg/mL bivalirudin for use as an anticoagulant in patients undergoing percutaneous coronary intervention (NYSE: PCI) (with the use of a glycoprotein IIb/IIIa inhibitor), patients undergoing PCI with or at risk of heparin-induced thrombocytopenia (low platelets) and thrombosis syndrome and patients with unstable angina undergoing percutaneous transluminal coronary angioplasty. A CRL means that, in the FDA's view, the application is not approvable in its present form. Specifically, the agency requested further characterization of bivalirudin-related substances in the drug product. The company remains committed to KANGIO, a ready-to-use formulation of The Medicines Company's Angiomax (bivalirudin), and will work closely with the FDA to address the deficiencies and clarify a path forward. Shares are down 16% premarket on modest volume.

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