Unichem Laboratories receives ANDA approval for Losartan Potassium and Hydrochlorothiazide tablets USP

Losartan Potassium and Hydrochlorothiazide tablets to treat hypertension

Unichem Laboratories has received ANDA approval from the United States Food and Drug Administration (US FDA) for Losartan Potassium and Hydrochlorothiazide tablets USP, 50 mg/12.5 mg, 100 mg/12.5 mg and 100 mg/25 mg which are therapeutically equivalent to Hyzaar tablets 50 mg/12.5 mg, 100 mg/12.5 mg and 100 mg/25 mg of Merck Sharp and Dohme Corporation.

Losartan Potassium and Hydrochloeothiazide is a combination of Losartan Potassium, an angiotensin II receptor blocker (ARB) and Hydrpchlorothiazide, a diuretic indicated for treatment of hypertension ( to lower blood pressure) and for reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy.

The product will be commercialized from Unichem’s Ghaziabad plant. Active Pharmaceutical Ingredient will also be made in house at Pithampur/ Roha API Plant.