FDA Gives Green Light to First Olmesartan Generics

Patrice Wendling


October 27, 2016

WASHINGTON, DC — The US Food and Drug Administration (FDA) has approved the first generic versions of four drugs that contain the widely used blood pressure-lowering medication olmesartan medoxomil—Benicar tablets, Benicar HCT tablets, Azor tablets, and Tribenzor tablets (all Daiichi Sankyo).

Benicar HCT, Azor, and Tribenzor combine olmesartan medoxomil in one pill with the blood pressure medications amlodipine besylate and hydrochlorothiazide, for patients who need multiple blood pressure medications, the FDA wrote in its announcement, posted October 26, 2016.

The four generics are available in several dosages and, like their brand name counterparts, are for oral use only.

The agency noted that approved drugs may not always be available on or after the approval date.

Olmesartan medoxomil is an angiotensin II receptor blocker, a class of drugs that when used during pregnancy can cause injury or death to the developing fetus. Labeling for olmesartan medoxomil contains a boxed warning about these risks during pregnancy. More information on olmesartan also may be found within the drug label.

Generic drugs approved by the FDA have the same high-quality and strength as brand-name drugs, and generic manufacturing and processing pass the same quality standards as those of brand-name drugs, the FDA release stated.

The full list of first-time generic drug approvals is available at First-Time Generic Drug Approvals.

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