ExantaTreatment for Oral Anticoagulation Therapy
AstraZeneca Receives Action Letter From FDA for Exanta (ximelagatran)
WILMINGTON, Del., October 08, 2004 -- AstraZeneca (NYSE:AZN) announced today that the US Food and Drug Administration (FDA) did not grant approval for the investigational oral anticoagulant Exanta (ximelagatran).
The company had submitted a New Drug Application (NDA) for Exanta for 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.
Following receipt of the letter, the company is considering how to proceed further with the FDA.
Exanta has been approved by European regulatory authorities for the prevention of blood clots in patients undergoing hip- and knee-replacement surgery, and has been launched in seven European markets. AstraZeneca continues to believe in the benefit/risk profile of Exanta and will work with European and other regulatory authorities towards further approvals.
Posted: October 2004
- FDA Advisory Committee Recommends Further Data to Support Approval of AstraZeneca's Oral Anticoagulant Exanta - September 10, 2004