Exanta
Generic name: ximelagatran
Treatment 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
Related articles
- FDA Advisory Committee Recommends Further Data to Support Approval of AstraZeneca's Oral Anticoagulant Exanta - September 10, 2004
Exanta (ximelagatran) FDA Approval History
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
