New & Noteworthy

December 2016

Injectable Generic Drug

Fresenius Kabi USA

Fresenius Kabi announces the availability of Bivalirudin for injection, a generic alternative to Angiomax. Available in single-dose vials, each containing 250 mg of Bivalirudin, the direct thrombin inhibitor is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA), those undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as in the REPLACE-2 study, or those with or at risk of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS) undergoing PCI. Bivalirudin for Injection is intended for use with aspirin; safety and effectiveness are not established in patients with acute coronary syndromes who are not undergoing PTCA or PCI.

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