Content about Atrial fibrillation

January 17, 2014

Par Pharmaceutical on Thursday announced that it has entered into an exclusive U.S. supply and distribution agreement with Covis Pharma S.a.r.l. to distribute the authorized generic version of Covis's Lanoxin (digoxin) tablets.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical on Thursday announced that it has entered into an exclusive U.S. supply and distribution agreement with Covis Pharma S.a.r.l. to distribute the authorized generic version of Covis's Lanoxin (digoxin) tablets. 

According to IMS Health data, annual U.S. sales of digoxin tablets are approximately $44 million. 

January 8, 2014

Japanese drug maker Daiichi Sankyo is seeking Food and Drug Administration approval for a once-daily tablet to reduce the risk of stroke in patients with atrial fibrillation and treatment of other conditions.

PARSIPPANY, N.J. — Japanese drug maker Daiichi Sankyo is seeking Food and Drug Administration approval for a once-daily tablet to reduce the risk of stroke in patients with atrial fibrillation and treatment of other conditions.

Daiichi Sankyo announced the submission of a new drug application for Savaysa (edoxaban). The company also is hoping to get the FDA's approval for the pill as a treatment for deep vein thrombosis and pulmonary embolism, as well as preventing the recurrence of symptomatic venous thromboembolism.

August 15, 2013

Boehringer Ingelheim, a research-based, global pharmaceutical company, today announced a multi-year agreement with Brigham and Women's Hospital on a long-term study program to assess comparative effectiveness and safety, as well as prescribing patterns, of oral anticoagulants, including Pradaxa, for the reduction of stroke risk in U.S. patients with non-valvular atrial fibrillation.

RIDGEFIELD, Conn. — Boehringer Ingelheim, a research-based, global pharmaceutical company, today announced a multi-year agreement with Brigham and Women's Hospital on a long-term study program to assess comparative effectiveness and safety, as well as prescribing patterns, of oral anticoagulants, including Pradaxa, for the reduction of stroke risk in U.S. patients with non-valvular atrial fibrillation.

January 2, 2013

The Food and Drug Administration last week approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation that is not caused by a heart valve problem. Eliquis is manufactured by Bristol-Myers Squibb, and marketed by BMS and Pfizer.

PRINCETON, N.J. — The Food and Drug Administration last week approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots in patients with atrial fibrillation that is not caused by a heart valve problem. Eliquis is manufactured by Bristol-Myers Squibb, and marketed by BMS and Pfizer.

May 24, 2012

A Food and Drug Administration expert panel has recommended against expanding the approval of a Johnson & Johnson drug, the company said.

RARITAN, N.J. — A Food and Drug Administration expert panel has recommended against expanding the approval of a Johnson & Johnson drug, the company said.

J&J subsidiary Janssen Research & Development said the FDA's Cardiovascular and Renal Drugs Advisory Committee voted against recommending approval of Xarelto (rivaroxaban) combined with antiplatelet drugs to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome.

May 3, 2012

Drug maker Johnson & Johnson is seeking approval from the Food and Drug Administration for a drug to treat patients with deep vein thrombosis or pulmonary embolism, the company said.

RARITAN, N.J. — Drug maker Johnson & Johnson is seeking approval from the Food and Drug Administration for a drug to treat patients with deep vein thrombosis or pulmonary embolism, the company said.

J&J division Janssen Research & Development announced the submission of a supplemental new drug application for Xarelto (rivaroxaban) to the FDA for the two conditions and for preventing recurrent venous thromboembolism.

November 29, 2011

A drug designed to prevent stroke and systemic embolism in patients with atrial fibrillation has been accepted for review by the Food and Drug Administration.

NEW YORK and PRINCETON, N.J. — A drug designed to prevent stroke and systemic embolism in patients with atrial fibrillation has been accepted for review by the Food and Drug Administration.

Bristol-Myers Squibb and Pfizer said their investigational compound Eliquis (apixaban) was accepted for review and granted a priority-review designation. The companies submitted the application to the agency after completing two phase-3 trials, which examined the efficacy and safety of Eliquis among about 24,000 patients.

November 7, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for preventing stroke in patients with abnormal heart rhythm, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for preventing stroke in patients with abnormal heart rhythm, the agency said.

The agency announced Friday the approval of Xarelto (rivaroxaban), an anti-clotting made by J&J subsidiary Janssen Pharmaceuticals, in patients with non-valvular atrial fibrillation. The FDA approved the drug in the 10-mg strength in July for deep-vein thrombosis in patients receiving knee and hip replacement surgery. The latest approval includes 15-mg and 20-mg strengths.

September 13, 2011

Singer and atrial fibrillation patient Barry Manilow has joined Sanofi's national education campaign designed to raise awareness about atrial fibrillation.

NEW YORK — Singer and atrial fibrillation patient Barry Manilow has joined Sanofi's national education campaign designed to raise awareness about atrial fibrillation.

The Get Back in Rhythm campaign aims to improve the health and well-being of those affected by the condition by encouraging them to learn more about the risks and talk with their healthcare provider about how to maintain a normal heart rhythm and manage the disease.

August 29, 2011

A drug made by Pfizer and Bristol-Myers Squibb undergoing late-stage clinical trials was more effective than the generic drug warfarin in patients with atrial fibrillation, according to study results released Sunday.

NEW YORK — A drug made by Pfizer and Bristol-Myers Squibb undergoing late-stage clinical trials was more effective than the generic drug warfarin in patients with atrial fibrillation, according to study results released Sunday.

The phase-3 "ARISTOTLE" trial of Eliquis (apixaban) showed that the drug reduced the risk of stroke and systemic embolism by 21%, major bleeding by 31% and death by 11% in AF patients. The study, published in the New England Journal of Medicine, was conducted at 1,034 centers in 39 countries and enrolled 18,201 patients.

March 15, 2011

A drug used to prevent stroke in patients with a form of atrial fibrillation has won preferred Tier 2 formulary status with pharmacy benefit managers Medco Health Solutions and CVS Caremark.

RIDGEFIELD, Conn. — A drug used to prevent stroke in patients with a form of atrial fibrillation has won preferred Tier 2 formulary status with pharmacy benefit managers Medco Health Solutions and CVS Caremark.

Boehringer Ingelheim Pharmaceuticals announced Monday that CVS Caremark and Medco had added Pradaxa (dabigatran etexilate mesylate) capsules to their commercial preferred drug lists, and Medco had added the drug to its Part D drug list.

February 14, 2011

An investigational drug made by Bristol-Myers Squibb works better than aspirin in reducing the risk of complications in certain patients with heart rhythm problems, according to results of a late-stage clinical trial published in the New England Journal of Medicine.

NEW YORK — An investigational drug made by Bristol-Myers Squibb works better than aspirin in reducing the risk of complications in certain patients with heart rhythm problems, according to results of a late-stage clinical trial published in the New England Journal of Medicine.

Bristol said results of the phase-3 study comparing apixaban with aspirin showed that in patients with atrial fibrillation who were not suited to take the drug warfarin, apixaban was more effective than aspirin in reducing stroke and systemic embolism.

February 4, 2011

The cardiovascular drug market will turn into a difficult conquest in the years to come as it increasingly will be dominated by generics, but that isn’t stopping drug companies from continuing to develop treatments — 299 of them, according to a recent report by the Pharmaceutical Research and Manufacturers of America — for high cholesterol, hypertension, atrial fibrillation, heart failure and other heart-related conditions.

WHAT IT MEANS AND WHY IT'S IMPORTANT — The cardiovascular drug market will turn into a difficult conquest in the years to come as it increasingly will be dominated by generics, but that isn’t stopping drug companies from continuing to develop treatments — 299 of them, according to a recent report by the Pharmaceutical Research and Manufacturers of America — for high cholesterol, hypertension, atrial fibrillation, heart failure and other heart-related conditions.

January 3, 2011

Omega-3 fatty acids from seafood may reduce inflammation and symptoms of gum disease and risk of abnormal heartbeats, according to recent articles in the December 2010 PUFA Newsletter and Fats of Life e-newsletters for health professionals and consumers.

DENVER — Omega-3 fatty acids from seafood may reduce inflammation and symptoms of gum disease and risk of abnormal heartbeats, according to recent articles in the December 2010 PUFA Newsletter and Fats of Life e-newsletters for health professionals and consumers.

October 19, 2010

The Food and Drug Administration approved a drug for preventing strokes and blood clots in...

SILVER SPRING, Md. The Food and Drug Administration approved a drug for preventing strokes and blood clots in patients with abnormal heart rhythm, the agency said Tuesday.

 

The FDA announced the approval of Pradaxa (dabigatran etexilate) capsules, an anticlotting drug made by Boehringer Ingelheim for patients with atrial fibrillation, a type of abnormal heart rhythm that affects more than 2 million Americans.

 

 

September 20, 2010

A Food and Drug Administration advisory committee has recommended approval of a drug for patients...

RIDGEFIELD, Conn. A Food and Drug Administration advisory committee has recommended approval of a drug for patients with atrial fibrillation.

 

The FDA cardiovascular and renal drugs advisory committee voted unanimously to recommend approval for Boehringer Ingelheim's Pradaxa (dabigatran etexilate), for preventing strokes in atrial fibrillation patients. For the last 50 years, warfarin has been the only oral anticoagulant drug available for this purpose.

 

 

May 13, 2010

An investigational drug for treating a common form of abnormal heart rhythm works better than...

March 17, 2010

An investigational pill reduced bleeding in patients with atrial fibrillation better than a widely available...