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Exanta Approval Status

Exanta (ximelagatran) is an investigational oral direct thrombin inhibitor (oral DTI) intended for use in the prevention of strokes in patients with atrial fibrillation, for the prevention of blood clots in patients undergoing knee-replacement surgery, and for the long-term secondary prevention of blood clots following standard treatment of a clot.

In October 2004, AstraZeneca announced the receipt of a Not Approvable Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application (NDA) for Exanta (ximelagatran) had not been approved.

Development Status and FDA Approval Process for Exanta

Oct  8, 2004AstraZeneca Receives Action Letter From FDA for Exanta (ximelagatran)
Sep 10, 2004FDA Advisory Committee Recommends Further Data to Support Approval of AstraZeneca's Oral Anticoagulant Exanta

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