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FDA Approves EDARBYCLOR (azilsartan medoxomil and chlorthalidone) for the Treatment of Hypertension
Date:12/20/2011

a> for complete EDARBYCLOR Prescribing Information.

Indications and Usage
EDARBI and EDARBYCLOR are indicated for the treatment of hypertension to lower blood pressure. EDARBI is an angiotensin II receptor blocker (ARB) and EDARBYCLOR is an ARB and a thiazide-like diuretic combination. EDARBYCLOR may be used if not adequately controlled on monotherapy or as initial therapy if a patient is likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. There are no controlled trials demonstrating risk reduction with EDARBI or EDARBYCLOR, but trials with chlorthalidone and at least one pharmacologically similar drug to azilsartan medoxomil have demonstrated such benefits.

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. Many patients will require more than one drug to achieve blood pressure goals. EDARBI and EDARBYCLOR may be used with other antihypertensive agents.

Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, and gastroenterology and cardiovascular treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.
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SOURCE Takeda Pharmaceuticals North America, Inc.
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