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Generic Versions of Cozaar and Hyzaar Approved for the Treatment of Hypertension
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.
Losartan potassium tablets are approved in 25 milligram, 50 mg, and 100 mg strengths, and Losartan potassium and hydrochlorothiazide tablets are approved in 50 mg/12.5 mg, 100mg/12.5 mg, and 100 mg/25 mg strengths. Both products are manufactured by TEVA Pharmaceuticals USA 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. These companies include Mylan Pharmaceuticals Inc., Roxane Laboratories Inc., and Torrent Pharmaceuticals Ltd.
Source: Food and Drug Administration