Unichem Labs gets FDA green light for generic Hygroton
Unichem Laboratories has received the Food and Drug Administration's nod for chlorthalidone tablets in dosage strengths of 25 mg and 50 mg. The product is the generic of Sanofi Aventis’ Hygroton tablets, 25 mg and 50 mg.
It 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; and adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy; and 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.