Amlodipine News and Research

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Mylan enters settlement agreement with Pfizer for Caduet Tablets litigation

Mylan Inc. today announced that it has entered into a settlement agreement with Pfizer Inc. resolving litigation related to Caduet® Tablets, 2.5 mg/10, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg, known generically as Amlodipine Besylate/Atorvastatin Calcium Tablets.

25 Jan 2011

Combination therapy initially, best for blood pressure control: ACCELERATE study

A new study published online Jan. 13 in The Lancet shows that patients with high blood pressure respond better to a combination drug therapy than those on monotherapy. Also patients who undergo the two-drug treatment after taking the single-drug therapy also experience better blood pressure outcomes, though not at the same level as those who began with the combination treatment, according to research.

13 Jan 2011

FDA approves Novartis' Amturnide for treatment of high blood pressure

Today Novartis announced that the US Food and Drug Administration (FDA) approved Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure. Amturnide combines the only approved direct renin inhibitor worldwide, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).

23 Dec 2010

Watson Laboratories receives FDA approval for Amlodipine capsules

Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Amlodipine Besylate/Benazepril 5/20mg, 10/20mg, 2.5/10mg, and 5/10mg capsules, the generic equivalent to Novartis' Lotrel capsules.

15 Oct 2010

EMA approves TWYNSTA therapy that reduces BP in hypertensive patients

Boehringer Ingelheim announced today that the European Commission confirmed the positive opinion of the European Medicines Agency (EMA) approving TWYNSTA. TWYNSTA is indicated for the treatment of hypertension in adults whose blood pressure is not adequately controlled on amlodipine or as replacement therapy in adult patients receiving telmisartan and amlodipine from separate tablets containing the same component doses.

12 Oct 2010

Telmisartan and amlodipine combination therapy helps achieve high BP control/response rates

Data show that treatment with a single-pill combination of telmisartan, an angiotensin receptor blocker, (ARB) and amlodipine, a calcium channel blocker (CCB) results in significant reductions in blood pressure (BP) in patients with severe hypertension.

31 Aug 2010

FDA approves Novartis' Tekamlo for treatment of high blood pressure

The US Food and Drug Administration (FDA) approved Tekamlo™ (aliskiren and amlodipine) tablets, a single-pill for the treatment of high blood pressure combining the only approved direct renin inhibitor, Tekturna® (aliskiren), with the widely used calcium channel blocker amlodipine. Tekamlo is approved as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals, and as replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren or amlodipine alone.

27 Aug 2010

Study examines comparative value of different blood pressure lowering medications

Expensive brand-name medications to lower blood pressure are no better at preventing cardiovascular disease than older, generic diuretics, according to new long-term data from a landmark study.Paul Whelton, MB, MD, MSc, reported the results on Aug. 13 at the plenary session of the China Heart Congress and International Heart Forum in Beijing. Whelton is president and CEO of Loyola University Health System and chairman of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heat Attack Trial (ALLHAT), which has examined the comparative value of different blood pressure-lowering medications.

13 Aug 2010

Boehringer Ingelheim announces European CHMP Positive Opinion for TWYNSTA

Boehringer Ingelheim announced today that the European Committee for Medicinal Products for Human Use (CHMP) adopted a Positive Opinion for the approval of TWYNSTA®. It will be indicated in adults whose blood pressure is not adequately controlled on amlodipine and is also indicated as replacement therapy in adult patients receiving telmisartan and amlodipine from separate tablets can instead receive tablets of TWYNSTA containing the same component doses.

26 Jul 2010

Study results of triple combination therapy in patients with diabetes and hypertension presented at ADA 2010

Preliminary results of a pre-specified subgroup study analysis of patients with diabetes and hypertension demonstrated that the investigational triple combination therapy of olmesartan medoxomil / amlodipine / hydrochlorothiazide (40/10/25 mg) resulted in a statistically significant greater Least Squares mean reduction in blood pressure from baseline at week 12 (37.9/22.0 mm Hg versus 26.4-28.0/14.7-17.6 mm Hg, P less than or equal to 0.0013) as compared to corresponding dual combination therapy [olmesartan medoxomil (40 mg) / amlodipine (10 mg); olmesartan medoxomil (40 mg) / hydrochlorothiazide (25 mg); or amlodipine (10 mg) and hydrochlorothiazide (25 mg)].

1 Jul 2010

Mylan-Nifedipine Extended Release tablets launched in Canada

Mylan Pharmaceuticals ULC today announces it has launched Mylan-Nifedipine Extended Release tablets in 30 mg strength. Mylan is the only company in Canada to offer this generic alternative to Adalat XL. Previously available in 60 mg tablets, the addition of the 30 mg is another example of how generic manufacturers offer patients greater access to high quality products.

5 May 2010

Triple combination therapy with OM, AML, HCTZ more effective at lowering blood pressure

Results of a new study found that the investigational triple combination therapy of olmesartan medoxomil (OM), amlodipine besylate (AML), and hydrochlorothiazide (HCTZ) demonstrated significantly greater mean reductions at week 12 in blood pressure (37.1/21.8 mm Hg versus 27.5 to 30.0/15.1-18.0 mm Hg LS Mean Reductions, P< 0.0001), as compared to corresponding dual combination therapy (dual components).

3 May 2010

Takeda announces submission of azilsartan medoxomil NDA for hypertension to FDA

Takeda Pharmaceutical Company Limited (Takeda) announced today that Takeda Global Research & Development Center, Inc., U.S., submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for azilsartan medoxomil (development code: TAK-491), an angiotensin II receptor blocker (ARB) under investigation for the treatment of hypertension. Discovered by Takeda, azilsartan medoxomil is designed to lower blood pressure by blocking the action of a vasopressor hormone, angiotensin II.

28 Apr 2010

Amlodipine benazepril capsules for treatment of hypertension launched in the US market

Dr. Reddy's Laboratories announced today that it launched amlodipine benazepril capsules (2.5mg/10mg, 5mg/10mg, 5mg/20mg, 10mg/20mg), a bioequivalent generic version of Lotrel Capsules, in the US market on April 23, 2010.

26 Apr 2010

Almost 62% of Canadians age 65 and older use five or more classes of prescription drugs: CIHI study

Almost two-thirds (62%) of Canadians age 65 and older living in the community in six provinces are using five or more classes of prescription drugs, according to a study released today by the Canadian Institute for Health Information.

19 Mar 2010

Teva Pharmaceutical Industries announces fourth-quarter and full-year 2009 financial results

Teva Pharmaceutical Industries Ltd. today reported record results for the quarter and year ended December 31, 2009.

16 Feb 2010

FDA approves Lupin Pharmaceuticals' Amlodipine/Benazepril capsules

Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (U.S. FDA) has granted final approval for its Amlodipine/Benazepril 2.5mg/10mg, 5mg/10mg, 5mg/20mg and 10mg/20mg capsules. Commercial shipments of the product have already commenced.

9 Feb 2010

Mylan first to file ANDA patent for Caduet Tablets

Mylan Inc. today confirmed that it was sued by Pfizer in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Amlodipine Besylate and Atorvastatin Calcium Tablets 2.5/10 mg, 2.5/20 mg, 2.5/40 mg, 5/10 mg, 5/20 mg, 5/40 mg, 5/80 mg, 10/10 mg, 10/20 mg, 10/40 and 10/80 mg.

5 Feb 2010

AIIRA/CCB drug combination provides superior safety and efficacy compared to other fixed-dose combinations

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a hypertension drug that requires less-frequent dosing than Novartis's Diovan/Tareg (valsartan) would earn 30 percent patient share according to surveyed U.S. cardiologists

9 Jan 2010

Non-clinical data from Cytokinetics' smooth muscle contractility program presented

Cytokinetics, Incorporated announced today that three abstracts summarizing non-clinical data regarding its smooth muscle contractility program were presented at the 2009 Scientific Sessions of the American Heart Association in Orlando, Florida.

17 Nov 2009