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Aventis Refludan

Executive Summary

Lepirudan (rDNA) for injection receives FDA "non-approvable" letter May 11 for treatment of anticoagulation in patients with acute coronary syndrome. The supplemental application was turned down by an FDA advisory committee May 2 (1"The Pink Sheet" May 8, p. 29). There are no ongoing or planned Refludan trials at this time, Aventis said

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