AstraZeneca Exanta review
Executive Summary
Direct thrombin inhibitor Exanta (ximelagatran) will be reviewed by FDA's Cardiovascular & Renal Drugs Advisory Committee on Sept. 10. AstraZeneca is seeking indications for the prevention of thromboembolism in patients undergoing knee replacement surgery and patients with atrial fibrillation. The company is also seeking use for secondary prevention of venous thromboembolism after standard treatment of a venous thromboembolic event. The meeting will be held at the CDER advisory committee conference room in Rockville, Md., beginning at 8:30 a.m...
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