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AstraZeneca H376/95

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Company expects to file an NDA for the oral direct thrombin inhibitor in the second half of 2002 for prevention of venous thromboembolism in orthopedic surgery. The NDA filing was originally planned for 2001 but Phase III trials of the product did not achieve statistical superiority over comparator products enoxaparin and warfarin, according to the company. A submisison for prevention of stroke in atrial fibrillation is expected in the second quarter of 200
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