FDA Approves First Generic Formulations of Losartan for Hypertension

Yael Waknine

April 09, 2010

April 9, 2010 — The US Food and Drug Administration (FDA) has approved the first generic formulations of losartan potassium tablets, alone and in combination with hydrochlorothiazide (Cozaar and Hyzaar, Merck & Company, Inc), for the treatment of hypertension.

Losartan tablets have been approved in 25-mg, 50-mg, and 100-mg doses; losartan/hydrocholorothiazide combination tablets will be available in strength of 50 mg/12.5 mg, 100 mg/12.5 mg, and 100 mg/25 mg (Teva Pharmaceuticals, USA).

The 100 mg/12.5 mg losartan/hydrochlorothiazide formulation will also be manufactured by several other companies, including Mylan Pharmaceuticals Inc, Roxane Laboratories Inc, and Torrent Pharmaceuticals Ltd.

According to FDA officials, the generic losartan products will carry the same safety concerns as their brand counterparts, including a boxed warning against usage during the second and third trimesters of pregnancy.


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