FDA approves first generic losartan formulations

Yael Waknine

April 09, 2010

Silver Spring, MD - The US Food and Drug Administration (FDA) has approved the first generic formulations of losartan potassium tablets, alone (Cozaar, Merck) and in combination with hydrochlorothiazide (Hyzaar, Merck), for the treatment of hypertension[1].

Losartan tablets have been approved in 25-mg, 50-mg, and 100-mg doses, and losartan/hydrochlorothiazide combination tablets will be available in 50-mg/12.5-mg, 100-mg/12.5-mg, and 100-mg/25-mg strengths, manufactured by Teva Pharmaceuticals.

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

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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