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Azilsartan tablets approved to treat hypertension
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The FDA has announced the approval of azilsartan medoxomil, an angiotensin II receptor blocker, for the treatment of hypertension in adults.
Azilsartan medoxomil tablets (Edarbi, Takeda Pharmaceuticals) will be made available in 80-mg and 40-mg doses. The FDA approved the drug based on data from more than 5,900 patients showing that azilsartan was more effective at lowering 24-hour blood pressure compared with valsartan (Diovan, Novartis) and olmesartan (Benicar, Daiichi Sankyo).
The 40-mg dose will be available for patients taking high-dose diuretics, according to a press release.
“High BP is often called the ‘silent killer’ because it usually has no symptoms until it causes damage to the body,” Norman Stockbridge, MD, PhD, director of the division of cardiovascular and renal drugs products at the FDA’s Center for Drug Evaluation and Research, said in the press release. “High BP remains inadequately controlled in many people diagnosed with the condition, so having a variety of treatment options is important.”
The boxed warning that accompanied azilsartan specified that the drug not be used in pregnant women during the second or third trimester.
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