The FDA has filed a supplemental New Drug Application for Pradaxa® (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis and pulmonary embolism in patients who have had primary elective total hip replacement surgery. If approved, this will become the fourth indication for Pradaxa®.

“Total hip replacement is a common procedure, and preventive anticoagulant treatment is recommended” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “The acceptance of this [application] is another step toward expanding the therapeutic uses for Pradaxa® to improve patient outcomes in this population.”