US Pharm. 2010;35(6)(Generic Drug Review suppl):42.
The FDA approved the first generic versions of Cozaar (losartan potassium tablets) and Hyzaar tablets (losartan potassium and hydrochlorothiazide tablets), used to treat hypertension. Cozaar and Hyzaar tablets are commonly prescribed antihypertensive drugs, and both generic losartan products will carry the same safety warnings as their brand counterparts, such as a boxed warning against use during the second and third pregnancy trimesters.
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 USA. In related actions, the FDA also approved applications from several other companies, including Mylan Pharmaceuticals Inc., Roxane Laboratories Inc., and Torrent Pharmaceuticals Ltd., for losartan potassium and hydrochlorothiazide tablets for the 100-mg/12.5-mg strength only.
