Drug Information Update: FDA Approves First Generic Versions of Two Drugs for the Treatment of Hypertension

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Title: Drug Information Update: FDA Approves First Generic Versions of Two Drugs for the Treatment of Hypertension

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.


On April 6, the U.S. Food and Drug Administration approved the first generic versions of two drugs used for the treatment of hypertension. Losartan potassium tablets and losartan potassium and hydrochlorothiazide tablets (a combination drug) are the generic equivalents of Cozaar and Hyzaar tablets, respectively.

Cozaar and Hyzaar tablets are widely-used antihypertensive drugs. Both generic losartan products will carry the same safety warnings as their brand counterparts. These warnings include a boxed warning against the use of these products during the second and third trimesters of pregnancy.

For more information please visit:  Losartan


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