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First generic antihypertensives approved

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The FDA this week approved losartan potassium tablets and the combination therapy losartan potassium plus hydrochlorothiazide for treating hypertension, according to a press release.

These are generic versions of Cozaar (Merck) and Hyzaar (Merck) tablets, the agency stated, and both will carry the same boxed warnings against use in the second and third trimesters of pregnancy that their brand name counterparts carry.

Losartan potassium tablets have been approved in 25-mg, 50-mg and 100-mg doses, and the combination therapy of losartan potassium plus hydrochlorothiazide is approved in 50-mg/12.5-mg, 100-mg/12.5-mg and 100-mg/25-mg doses.

The newly approved generic formulations are manufactured by Teva Pharmaceuticals USA, based in Pennsylvania. The FDA has also approved applications from Mylan Pharmaceuticals, Roxane Laboratories and Torrent Pharmaceuticals for the losartan potassium plus hydrochlorothiazide tablets at 100-mg/12.5-mg strength only, according to the press release.

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