The Medicines Company Authorizes Launch of Generic Angiomax

July 9, 2015—The Medicines Company announced an agreement with Sandoz Inc. for the distribution in the United States of an authorized generic of Angiomax (bivalirudin) for injection.

Angiomax is indicated in patients undergoing percutaneous coronary intervention (PCI) with provisional use of a glycoprotein IIb/IIIa inhibitor and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome undergoing PCI. Angiomax is also indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin and is not approved for use in patients with acute coronary syndromes not undergoing PCI or PTCA, advised the company.

On June 22, the company announced the US Food and Drug Administration approval of Kengreal (cangrelor), with a launch expected in July. Kengreal is approved as an adjunctive therapy to PCI for reducing periprocedural thrombotic events in patients who have not been treated with a P2Y12 inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor. European approval of cangrelor under the trade name Kengrexal was announced in March.