FDA OKs Hospira’s Generic AnticoagulantBy
The US Food and Drug Administration has approved Hospira’s bivalirudin for injection, a generic version of The Medicines Company’s anticoagulant, Angiomax. Hospira’s bivalirudin for injection is available in a single-dose flip-top vial, which matches the current branded offering available. In addition, Hospira plans to launch a differentiated presentation of the 250 mg bivalirudin for injection in Hospira’s ADD-Vantage vial.
Branded sales of Angiomax in 2014 in the United States were approximately $500 million, according to information from Hospira. Bivalirudin for injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA); in patients undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor (GPI); in patients with or at risk of heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS), undergoing PCI.