Roxane Labs gets tentative approval for generic Hyzaar

ROCKVILLE, Md. Generic drug maker Roxane Labs has received tentative approval for a generic version of a drug used to treat hypertension, according to Food and Drug Administration records.

The FDA gave Roxane tentative approval for losartan potassium and hydrochlorothiazide tablets in the 50-mg and 12.5-mg and 100-mg and 25-mg strengths. The tablets are a generic version of Merck & Co.’s Hyzaar.

Hyzaar and Cozaar, which contains losartan potassium only, had combined global sales of $3.6 billion in 2008, according to Merck financial data.