FDA approves Takeda's Edarbyclor

DEERFIELD, Ill. — The Food and Drug Administration has approved a new drug for high blood pressure made by Takeda, the drug maker said.

The Japanese drug maker received approval for Edarbyclor (azilsartan medoxomil and chlorthalidone) for the treatment of high blood pressure, also known as hypertension. The company called it the only fixed-dose therapy that combines an angiotensin II receptor blocker with chlorthalidone, a diuretic, in a once-daily, single tablet. The company also markets Edarbi, which only contains azilsartan medoxomil.

"Hypertension is a complex disease that affects one-in-three Americans," Virginia Commonwealth University Medical Center professor Domenic Sica said in a statement on behalf of Takeda. "It is critical to control hypertension because lowering blood pressure has been shown to reduce the risk of serious health consequences, including stroke and heart attack."


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