Pharmaceutical company Mylan NV (NASDAQ:MYL) reported on Monday the market availability of Bivalirudin for Injection in 250 mg single-dose vial in the US anticoagulant market.
The company said the Bivalirudin for Injection in 250 mg single-dose vial is the generic version of Angiomax from The Medicines Company. Bivalirudin for Injection is an anticoagulant intended for use with aspirin.
Following US FDA approval of its Abbreviated New Drug Application (ANDA) for Bivalirudin for Injection in 250 mg single-dose vial, the company is now marketing the product to its hospital and institutional customers 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 well as with, or at risk of, heparin-induced thrombocytopenia (HIT) or heparin induced thrombocytopenia and thrombosis syndrome (HITTS).
For the 12 months ending 31 March 2018, Bivalirudin for Injection in 250 mg single-dose vial had US sales of approximately USD106m, according to IQVIA.
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