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news.Hospira had received approval from the US Food and Drug Administration (FDA) to launch bivalirudin for injection, a generic version of The Medicines Company's Angiomax.
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The company said that its bivalirudin for injection is available in a single-dose flip-top vial, which matches the current branded offering available.
Additionally, Hospira intends to launch a differentiated presentation of the 250mg bivalirudin for injection in its ADD-Vantage vial.
Hospira US Commercial president Philippe Drouet said: "Hospira is excited to launch the first generic of bivalirudin based on a successful challenge of the originator’s patents.
"This approval further demonstrates our commitment to bringing safe, lower-cost generic versions of important medications to the market as soon as possible."
Hospira’s bivalirudin for injection, available as a lyophilized (powder) format, is a direct thrombin inhibitor indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).
It can be used in patients undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as in the REPLACE-2 study and in people who are with, or at risk of, heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS), undergoing PCI.
Hospira’s specialty injectable pharmaceuticals (SIP) offering includes around 200 generic injectable drugs in many dosages and formulations.