BiznextIndia : Unichem Laboratories Limited on Monday announced that it has received ANDA approval from USFDA for it’s Chlorthalidone Tablets USP, 25 mg and 50 mg to market a generic version of Hygroton® Tablets, 25 mg and 50 mg of Sanofi Aventis US, LLC.
The drug is indicated for the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. It is also indicated for the management of adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. The drug is also used for the treatment of edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. The Product will be commercialized from Unichem’s Ghaziabad plant.