FDA approves first generic anti-hypertensives

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The FDA has 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, which are the generic equivalents of Cozaar and Hyzaar tablets, respectively.

Cozaar/Hyzaar tablets (Merck in Whitehouse Station, N.J.) are widely-used antihypertensive drugs, said the FDA, adding that both generic losartan products will carry the same safety warnings as their brand counterparts. The warnings include a boxed warning against the use of these products during the second and third trimesters of pregnancy.

According to the agency, losartan potassium tablets are approved in 25 mg, 50 mg, and 100 mg strengths, and losartan potassium and hydrochlorothiazide tablets are approved in 50 mg/12.5 mg, 100 mg/12.5 mg, and 100 mg/25 mg strengths. Both products are manufactured by Teva Pharmaceuticals in North Wales, Pa.

In related actions, the FDA also approved applications from several other companies for losartan potassium and hydrochlorothiazide tablets for the 100 mg/12.5 mg strength only. The companies include Mylan Pharmaceuticals in Canonsburg, Pa., Roxane Laboratories in Columbus, Ohio, and Torrent Pharmaceuticals in Torrent Pharmaceuticals.