Mylan NV (NASDAQ: MYL), a global pharmaceutical company, announced yesterday its launch of Bivalirudin for Injection, 250mg single-dose vial, a generic version of Angiomax from The Medicines Company, in the United States.
The product is a direct thrombin inhibitor indicated for use as an anticoagulant in patients.
The company is offering Bivalirudin for Injection, 250mg single-dose vial, to its hospital and institutional customers after an Abbreviated New Drug Application (NDA) for the product was approved by the US Food and Drug Administration (FDA). The product is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty; undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as in the REPLACE-2 study or with, or at risk of, heparin-induced thrombocytopenia (HIT) or heparin induced thrombocytopenia and thrombosis syndrome (HITTS), undergoing PCI. It is intended for use in these indications with aspirin.
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