Israeli drugmaker Teva Pharmaceutical has announced that the U.S. FDA has granted tentative approval for its abbreviated new drug application (ANDA) for losartan potassium and hydrochlorothiazide tablets. Final approval is expected upon expiration of patent protection in April 2010.
Upon final approval, the tablets will be the generic equivalent of Merck's Hyzaar Tablets. This product is indicated for treatment of hypertension and to reduce stroke in hypertensive patients with left ventricular hypertrophy.
According to Teva, annual sales of the brand product are approximately $542 million.