FDA Approves First Olmesartan Generics

The FDA has approved the first generic versions of 4 drugs―Benicar tablets, Benicar HCT tabets, Azor tablets, and Tribenzor tablets―that contain the widely used blood pressure-lowering medication olmesartan medoxomil.

The drugs combine olmesartan medoxomil in 1 pill with blood pressure medications amlodipine besylate and hydrochlorothiazide. They are indicated for patients who require multiple blood pressure medications. All 4 drugs are available for oral use in several dosages.

Olmesartan medoxomil is an angiotensin-2 receptor blocker that contains a boxed warning about risks of injury or death to a developing fetus during pregnancy.

The FDA announced the generics’ approval on October 26.