Boehringer Ingelheim seeks new approval of Pradaxa

Boehringer seeks approval for Pradaxa in treatment of deep vein thrombosis, pulmonary embolism

Associated Press

NEW YORK (AP) -- German drugmaker Boehringer Ingelheim said Wednesday it has filed for additional marketing approvals for its anticlotting drug Pradaxa.

The Food and Drug Administration accepted a marketing application for Pradaxa as a treatment for deep vein thrombosis and pulmonary embolism. A deep vein thrombosis is blood clot in a deep vein, usually in the leg or pelvis, that partly or completely blocks blood flow. A pulmonary embolism occurs when one of those blood clots travels to the lungs. That can create a life-threatening blockage.

Boehringer Ingelheim said there are 900,000 deep vein thrombosis and pulmonary embolism events per year in the U.S., and about a third of them result in death.

The FDA approved Pradaxa in October 2010 as a treatment for atrial fibrillation. Boehringer Ingelheim reported $796 million in worldwide sales in the first half of 2013.

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