Dronedarone (also known as Multaq) is a drug used mainly for the indication of cardiac arrhythmias (irregular heartbeat).
Boehringer Ingelheim Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration granted approval of Praxbind (idarucizumab). PRAXBIND is indicated for patients treated with Pradaxa (dabigatran etexilate mesylate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate mesylate) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. DVT and PE are collectively referred to as venous thromboembolism (VTE).
Boehringer Ingelheim, a research-based, global pharmaceutical company, today announced a multi-year agreement with Brigham and Women's Hospital, an internationally recognized teaching affiliate of Harvard Medical School known for its excellence in patient care, medical research and training of outstanding young health professionals.
New findings from two double-blind, randomized trials, RE-MEDY and RE-SONATE, show that dabigatran 150 mg twice daily reduces the risk of recurrent venous thromboembolism (VTE).
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. prescribing information for Pradaxa (dabigatran etexilate mesylate) capsules was updated to include a contraindication related to use in patients with mechanical prosthetic heart valve replacement.
The U.S. Food and Drug Administration (FDA) today announced the results of a Mini-Sentinel assessment that indicates bleeding rates associated with new use of Pradaxa (dabigatran etexilate mesylate) capsules do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the pivotal RE-LY trial.
Patients with the heart rhythm disorder atrial fibrillation (AFib) who received first-line catheter ablation treatment had a longer arrhythmia-free interval than patients receiving antiarrhythmic drugs, the standard first-line treatment.
New data show that, worldwide, one in three patients with atrial fibrillation (AF) who are at high risk for stroke are not being prescribed anticoagulant therapy, particularly vitamin K antagonists (VKA) – medicines known to significantly lower stroke risk in these patients.
The Guidelines Department of the European Society of Cardiology has issued the following statement today: "The European Society of Cardiology (ESC) is aware of the early termination of the PALLAS trial because of adverse outcomes associated with dronedarone.
Two studies to be presented this week address the often-overlooked costs associated with atrial fibrillation, the most common form of cardiac arrhythmia.
The Canadian Cardiovascular Society (CCS) presented its new 2010 Atrial Fibrillation Guidelines, the first update in six years, at the Canadian Cardiovascular Congress (CCC) in Montreal.
Sanofi-aventis announced today the initiation of a multinational, randomized double-blind Phase IIIb trial, PALLAS, to assess the potential clinical benefit of Multaq(R) (dronedarone) in over 10, 000 patients with permanent atrial fibrillation (AF) to reduce major adverse cardiovascular events. The announcement was made during Heart Rhythm 2010, the Heart Rhythm Society's 31st Annual Scientific Sessions.
In a rigorous new review of the antiarrhythmic drug dronedarone (Multaq), researchers at the Cedars-Sinai Heart Institute conclude that the controversial drug is only modestly effective and has no clear safety benefits.
Sanofi-aventis announced today that the National Institute for Health and Clinical Excellence (NICE) in England and Wales, has just published a new appraisal consultation document for Multaq(R) (dronedarone) indicating its intention to recommend Multaq(R) use for the management of patients with atrial fibrillation.
Physician scientists from the Cedars-Sinai Heart Institute presented new findings on the effectiveness of routine aspirin therapy for preventing heart disease, a drug therapy for atrial fibrillation and the role left ventricular assist devices may play in weight reduction for obese patients with chronic end-stage heart failure who are considered for heart transplantation.
Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, owing to the launches of several new agents, the atrial fibrillation drug market will increase more than sevenfold from $790 million in 2008 to $6.1 billion in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.
Sanofi-aventis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion recommending to grant a marketing authorization in the European Union for Multaq(R) (dronedarone - 400mg Tablets).
Sanofi-aventis Canada announced today that Multaq (dronedarone, 400 mg tablets) has received Health Canada approval for the treatment of patients with a history of, or current atrial fibrillation to reduce their risk of cardiovascular hospitalization due to this condition.
Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) has approved Multaq (dronedarone) 400 mg Tablets. Patients with atrial fibrillation (AF) or atrial flutter (AFL) soon will have a new treatment option to help improve current management of their disease. Multaq is the first drug approved in the United States that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with AF/AFL.
The U.S. Food and Drug Administration has approved Multaq tablets (dronedarone) to help maintain normal heart rhythms in patients with a history of atrial fibrillation or atrial flutter (heart rhythm disorders). The drug is approved to be used in patients whose hearts have returned to normal rhythm or who will undergo drug or electric-shock treatment to restore a normal heart beat.