FDA accepts sNDA for expanded use of Angiomax

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The FDA has accepted The Medicine Company's supplemental new drug application (sNDA) for a modified dosing regimen of Angiomax (bivalirudin) for the treatment of acute coronary syndrome, specifically in patients with unstable angina or non-segment elevation myocardial infarction.

The Medicines Company of Parsippany, N.J., expects the FDA to act on this filing in the second quarter of 2008. Currently, Angiomax is approved for patients undergoing angioplasty, or percutaneous coronary intervention.