Teva's losartan potassium and hydrochlorothiazide tablets will be the generic equivalent of Merck's Hyzaar.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has announced that the U S Food and Drug Administration has granted tentative approval for its abbreviated new drug application (ANDA) for Losartan Potassium and Hydrochlorothiazide Tablets, 50 mg/12.5 mg and 100 mg/25 mg.
Final approval is expected upon expiration of patent protection in April 2010.
Upon final approval, Teva's Losartan Potassium and Hydrochlorothiazide Tablets will be the AB-rated 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 (50 mg/12.5 mg and 100 mg/25 mg) are approximately $542 million.
Published by Globes [online], Israel business news - www.globes.co.il - on June 14, 2006
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