Content about Anticoagulants

March 17, 2014

Bristol-Myers Squibb Co. and Pfizer announced that the Food and Drug Administration approved a supplemental new drug application for Eliquis (apixaban). The drug is a preventive treatment for deep vein thrombosis, which can lead to pulmonary embolism for patients who have had hip or knee replacement surgery.

PRINCETON, N.J. and NEW YORK — Bristol-Myers Squibb Co. and Pfizer announced that the Food and Drug Administration approved a supplemental new drug application for Eliquis (apixaban). The drug is a preventive treatment for deep vein thrombosis, which can lead to pulmonary embolism for patients who have had hip or knee replacement surgery.  

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.

March 26, 2012

Sunpeaks Ventures last week announced national advertising support behind its Clotamin multivitamin line — a line of supplements formulated for use by patients on warfarin or other blood thinners.

SILVER SPRING, Md. — Sunpeaks Ventures last week announced national advertising support behind its Clotamin multivitamin line — a line of supplements formulated for use by patients on warfarin or other blood thinners.

"Until now, Clotamin has never been the focus of any consumer marketing," stated Mackie Barch, Sunpeaks CEO. "The product's popularity has been built solely through positive word of mouth from our customers and through pharmacies that already carry the product."

February 28, 2012

The Food and Drug Administration has given priority review to a regulatory application from Johnson & Johnson for a drug designed to reduce the risk of complications from internal blood clots.

RARITAN, N.J. — The Food and Drug Administration has given priority review to a regulatory application from Johnson & Johnson for a drug designed to reduce the risk of complications from internal blood clots.

J&J's Janssen Research & Development division announced that the FDA had given the designation to Xarelto (rivaroxaban), an oral anticoagulant, to reduce the risk of certain types of heart attacks in patients with acute coronary syndrome, which 1.2 million Americans are diagnosed with every year.

November 14, 2011

A drug under development by Pfizer and Bristol-Myers Squibb for preventing internal blood clots failed to show superiority over a treatment already on the market, the companies said Monday.

NEW YORK — A drug under development by Pfizer and Bristol-Myers Squibb for preventing internal blood clots failed to show superiority over a treatment already on the market, the companies said Monday.

The two drug makers announced Monday results of the phase-3 "ADOPT" study, which was designed to compare the safety and effectiveness of Eliquis (apixaban) with enoxaparin in preventing venous thromboembolism in patients with acute medical illness. Sanofi sells enoxaparin under the brand name Lovenox, and it is available as a generic.

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.

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.

July 15, 2011

The Food and Drug Administration has approved a generic anticoagulant drug made by Dr. Reddy’s Labs and Alchemia.

HYDERABAD, India — The Food and Drug Administration has approved a generic anticoagulant drug made by Dr. Reddy’s Labs and Alchemia.

Dr. Reddy’s and Brisbane, Australia-based Alchemia announced the FDA approval of fondaparinux sodium injection in the 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL and 10 mg/0.8 mL strengths. Alchemia owns the patents covering the process for synthesis of fondaparinux.

May 19, 2011

A drug for cardiovascular disease made by Boehringer Ingelheim has received preferred formulary status with AARP’s Medicare Part D plans, the drug maker said Thursday.

RIDGEFIELD, Conn. — A drug for cardiovascular disease made by Boehringer Ingelheim has received preferred formulary status with AARP’s Medicare Part D plans, the drug maker said Thursday.

BI announced that Pradaxa (dabigatran etexilate mesylate) received preferred Tier 2 formulary status through AARP’s pharmacy benefit manager, Prescription Solutions. The Food and Drug Administration approved Pradaxa in October 2010 to reduce the risk of stroke and embolism in patients with nonvalvular atrial fibrillation.

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.

January 25, 2011

Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

JERUSALEM — Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

November 14, 2010

An investigational drug made by Johnson & Johnson is more effective in reducing the risk...

CHICAGO An investigational drug made by Johnson & Johnson is more effective in reducing the risk of stroke in patients with a trial fibrillation than a widely available generic, the drug maker said Monday.

J&J announced results of the phase-3 “Rocket-AF” trial of rivaroxaban, saying results showed that a once-daily dose of the drug worked better than warfarin, the most commonly used drug for preventing stroke in AF patients. Rivaroxaban also was comparable in terms of safety.

November 8, 2010

Government officials said problems have arisen with the Food and Drug Administration’s approval of a...

NEW YORK Government officials said problems have arisen with the Food and Drug Administration’s approval of a generic blood-thinning drug due to its previous relationship with the generic drug’s manufacturer, according to published reports.

 

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.

 

 

August 23, 2010

French drug maker Sanofi-Aventis is suing to stop Sandoz’ generic version of its blood thinner...

July 22, 2010

The Food and Drug Administration has approved the first generic version of a Sanofi-Aventis injected...

SILVER SPRING, Md. The Food and Drug Administration has approved the first generic version of a Sanofi-Aventis injected drug used to treat deep vein thrombosis, the agency said Friday.

 

The FDA approved generic enoxaparin sodium, a version of Sanofi’s Lovenox, developed under a collaboration between Momenta Pharmaceuticals and Sandoz, the generics division of Swiss drug maker Novartis.

 

 

July 6, 2010

Launch and use of new heart drugs will drive the market for drugs to treat...

March 29, 2010

The Food and Drug Administration has given a tentative approval to a generic drug for...

March 17, 2010

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

March 7, 2010

A pill-based anticoagulant drug under development by Pfizer and Bristol-Myers Squibb worked better in reducing...

January 25, 2010

Sandoz is “confident” that it will win approval for a generic anti-clotting drug, according to...