February 25th, 2011
FDA Approves Azilsartan Medoxomil (Edarbi) for High Blood Pressure
The FDA has approved azilsartan medoxomil (Edarbi, Takeda) for the treatment of high blood pressure. The new angiotensin II receptor blocker (ARB) will be available in 80 mg and 40 mg doses. The recommended dose is 80 mg once daily. The 40 mg dose is used in combination with a diuretic.
The FDA said that, in clinical studies, azilsartan medoxomil was more effective than valsartan (Diovan) and olmesartan (Benicar) in lowering 24-hour blood pressure.
In a separate development, Takeda announced yesterday that it had submitted an NDA for a fixed-dose combination of azilsartan medoxomil plus chlorthalidone.