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Medicines Company To Undertake Two Hirulog Studies After Cmte. Rejection

Executive Summary

The Medicines Company is prepared to go ahead with two previously planned studies for Hirulog (bivalirudin) following an FDA advisory committee rejection of the anticoagulant.

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The Medicines Company Angiomax

FDA issues "approvable" letter May 11 for bivalirudin as an anticoagulant for patients with unstable angina undergoing percutaneous transluminal coronary angioplasty. In October 1998, FDA's Cardiovascular and Renal Drugs Advisory Committee declined to recommend the anticoagulant, formerly Hirulog, for approval (1"The Pink Sheet" Nov 2, 1998, p. 19)

The Medicines Company Angiomax

FDA issues "approvable" letter May 11 for bivalirudin as an anticoagulant for patients with unstable angina undergoing percutaneous transluminal coronary angioplasty. In October 1998, FDA's Cardiovascular and Renal Drugs Advisory Committee declined to recommend the anticoagulant, formerly Hirulog, for approval (1"The Pink Sheet" Nov 2, 1998, p. 19)

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