Approvals

FDA Approves Rivaroxaban for Stroke Prevention in AF Patients The approved indication of prevention of stroke and systemic embolism in nonvalvular atrial fibrillation is based primarily on the results of ROCKET-AF.
News, November 04, 2011
FDA Approves Diabetes and Cholesterol-Lowering Drug Combo Known as Juvisync, the new medication combines sitagliptin, a dipeptidyl peptidase-4 inhibitor used for glycemia control, with the cholesterol-lowering simvastatin.
News, October 07, 2011
EU Approves Dabigatran for AF Indication The warfarin alternative will be available in the 150-mg and 110-mg strengths for twice-daily administration, as studied in the RE-LY trial.
News, August 04, 2011
Ticagrelor Approved at Last for US Market: FDA After twice postponing a decision on ticagrelor, and asking for additional data, the FDA has made up its mind: the drug will soon be available for US patients.
News, July 20, 2011
FDA Approves Oral Anticoagulant Rivaroxaban for DVT Prevention at Surgery Approval of the once-daily oral factor Xa inhibitor, based on the RECORD trials, has been long awaited.
News, July 01, 2011
Ticagrelor Approved in Canada Health Canada has granted approval to ticagrelor for the secondary prevention of atherothrombotic events in patients with ACS. The FDA has twice postponed a decision on the drug.
News, June 01, 2011
FDA Approves Narrow Everolimus-Eluting Stent The FDA has approved an everolimus-eluting stent for coronaries as small as 2.25 mm in diameter. The same device will be marketed by Boston Scientific and Abbott under the Promus and Xience Nano brand names, respectively.
News, May 31, 2011
Apixaban Approved in Europe for Use After Hip/Knee Surgery This is the first approval of this drug worldwide. It will be sold under the brand name Eliquis.
News, May 20, 2011
FDA Approves Azilsartan, Another ARB, for Hypertension The drug will be available in 80-mg and 40-mg doses, although 80 mg is the recommended dose.
News, February 25, 2011
REVO Pacemaker Following the advice of its advisory panel, the FDA has approved Medtronic's premarket approval application for the REVO SureScan packing system, which is designed to be safe for magnetic resonance imaging.
News, February 09, 2011
Absorb Available in Europe The CE Mark approval is based on the ABSORB clinical trials, previously reported by heartwire, showing the feasibility of the dissolvingdevice and the durability of its antirestenotic properties.
News, January 10, 2011
First Triple Combo With Aliskiren Gets US Approval The FDA has approved a triple antihypertensive combination therapy with a direct renin inhibitor, along with a calcium channel blocker and a diuretic, the first such combination with the inhibitor.
News, December 27, 2010
Cryoballoon The FDA approves Medtronic's Arctic Front cryoablation balloon catheter based on the STOP-AF trial.
News, December 21, 2010
Assay for Fibrosis-Marker Galectin-3 for HF Risk Assessment The FDA has okayed an ELISA-based test for galectin-3, a biomarker thought to reflect progression of myocardial remodeling, for assessing risk in patients with chronic heart failure.
News, November 30, 2010
Dabigatran Approved for AF The long wait for an alternative to warfarin in the US is over. The drug will be available in two doses: 75 mg and 150 mg.
News, October 20, 2010
European CHMP Recommends Ticagrelor Approval It's now up to the European Commission to decide whether to grant approval for the clopidogrel competitor.
News, September 27, 2010
FDA Approves New CRT-D Indications FDA follows the advice of a March advisory panel in approving new indications for Boston Scientific cardiac resynchronization defibrillators.
News, September 17, 2010
New IV Antiarrhythmic Drug Approved in EU for Rapid Conversion of AF A novel intravenous drug, vernakalant, has been approved in the European Union, Iceland, and Norway for the rapid conversion of recent-onset atrial fibrillation to sinus rhythm in adults.
News, September 09, 2010
Ticagrelor Panel An FDA advisory panel voted overwhelmingly in favor of approval of AstraZeneca's antiplatelet agent Brilinta for preventing thrombotic events in patients with acute coronary syndrome.
News, July 28, 2010
Three-Drug Combo, Tribenzor, Approved for Resistant BP The new product combines the angiotensin-receptor blocker olmesartan, the calcium-channel blocker amlodipine, and the diuretic hydrochlorothiazide.
News, July 26, 2010

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