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Press Room
For Immediate Release: 5/2/2007
FDA Approves New Indication for FRAGMIN®
FDA Approves FRAGMIN® as First Low-Molecular-Weight-Heparin for Extended Treatment
to Reduce the Recurrence of Blood Clots in Patients with Cancer
Woodcliff Lake, NJ and New York, NY -- May 2, 2007 --The U.S. Food and Drug Administration (FDA) has approved a new indication for FRAGMIN® (dalteparin sodium injection), for the extended treatment of symptomatic venous thromboembolism (VTE) [proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE)] to reduce the recurrence of VTE in patients with cancer.
VTE is the formation of a blood clot that can travel from a leg vein to the lung, with potentially fatal results. FRAGMIN is the first low-molecular-weight heparin (LMWH) approved in the U.S. for the extended treatment of recurrent VTE in patients with cancer.
"Cancer treatments and the disease itself put this patient population at significantly higher risk than non-cancer patients for developing DVT or PE, the two conditions described as VTE," said Frederick Rickles, MD, FACP, clinical professor of medicine at George Washington University Medical Center.
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