Teva announces approval of generic Tribenzor in the United States.
Teva Pharmaceutical Industries Ltd., announced approval of generic Tribenzor1 (olmesartan medoxomil, amlodipine and hydrochlorothiazide) tablets in the U.S. and is in the final stages of launch preparation. Teva also recently received approval and launched generic Azor2 (amlodipine and olmesartan medoxomil) tablets in the U.S. These products enhance Teva’s antihypertensive portfolio.
Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets are a combination of an angiotensin II receptor blocker, a dihydropyridine calcium channel blocker and a thiazide diuretic indicated for the treatment of hypertension, to lower blood pressure.
Amlodipine and olmesartan medoxomil tablets are a dihydropyridine calcium channel blocker and angiotensin II receptor blocker combination product indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Many patients will require more than one drug to achieve their blood pressure goals.
Teva is committed to strengthening its generics business through continued investment in complex, high-quality products. With nearly 600 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market. These products enhance Teva’s already comprehensive product portfolio.
Teva has over 300 product registrations pending FDA approval and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in six generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
Tribenzor had annual sales of approximately $240 million in the U.S. and Azor® had annual sales of approximately $354.1 million in the U.S., according to IMS data as of August 2016.
Olmesartan medoxomil, amlodipine, hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil, amlodipine, hydrochlorothiazide tablets.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
Olmesartan medoxomil, amlodipine, hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension.
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Note:
1 Tribenzor is a registered trademark of Daiichi Sankyo Company.
2 Azor is a registered trademark of Daiichi Sankyo, Inc.
(Source: Business Wire)
