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FDA Approves New Indication for ARIXTRA(R) (fondaparinux sodium) Injection for Prevention of Venous Thromboembolism in Abdominal Surgery.

Publication: PR Newswire
Publication Date: 27-MAY-05 		Format: Online
Delivery: Immediate Online Access

Article Excerpt
Use of ARIXTRA Would Help Patients at Risk of Thromboembolic Complications

PHILADELPHIA, May 27 /PRNewswire-FirstCall/ -- The anti-thrombotic drug ARIXTRA(R) is now indicated for use in patients undergoing abdominal surgery, GlaxoSmithKline announced today. The U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for ARIXTRA in the prevention of venous thromboembolism (VTE) in patients undergoing abdominal surgery who are at risk of thromboembolic complications.

"Since many patients undergoing abdominal surgery are at high risk of developing VTE, the FDA's approval of ARIXTRA for this new indication represents an important and exciting medical development," said Kevin Lokay, vice president of GlaxoSmithKline Oncology and Acute Care. "This approval provides these high risk patients, particularly cancer surgery patients, the benefit of VTE protection in a once-a-day anticoagulant."

ARIXTRA is the first selective inhibitor of Factor Xa, a protein central to the coagulation process. ARIXTRA is already approved for the prevention of VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients undergoing surgery...

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