Warfarin, first approved in the 1950s, has been the standard of care and the only oral anticoagulant available in the U.S. for stroke reduction in patients with AFib.  Warfarin is efficacious in reducing the risk of stroke in patients with AFib when within its narrow therapeutic range.  In addition, it has the potential for interactions with many commonly used medications, as well as certain foods. As a result, patients taking warfarin must maintain a consistent diet and have their INR monitored and managed through regular blood tests and dose adjustments.

"This is a special moment which exemplifies innovation in modern medicine.  We are thrilled that the FDA's approval of PRADAXA will bring a novel medicine to patients with non-valvular atrial fibrillation," said Albert Ros, president and CEO, Boehringer Ingelheim Pharmaceuticals, Inc.  "This approval marks a proud moment in our company's 125-year history and is a shining example of how Boehringer Ingelheim is dedicated to innovating, developing and providing treatments to improve the lives of patients."

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.