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News From the Food and Drug Administration
February 14, 2001

New Anticoagulant Approved

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JAMA. 2001;285(6):724. doi:10.1001/jama.285.6.724-JFD10001-2-1

The FDA has approved bivalirudin injection (Angiomax; The Medicine Co, Cambridge, Mass) for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). Bivalirudin is intended for use only in patients receiving concomitant aspirin. Its safety and effectiveness have not been established when used in conjunction with other platelet inhibitors such as glucoprotein Ib/IIIa inhibitors, in patients not undergoing PTCA, or in patients with other acute coronary syndromes.