Unichem gets USFDA approval for high blood pressure drug Chlorthalidone

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Drug firm Unichem Laboratories has received approval from the US health regulator to market Chlorthalidone tablets, used to treat high blood pressure.

The company has received abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) for Chlorthalidone tablets USP in the strengths of 25 mg and 50 mg, Unichem Laboratories said in a regulatory filing.

The approved product is a generic version of Hygroton tablets, 25 mg and 50 mg of Sanofi Aventis US, LLC.

Hygroton tablets is indicated in 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, Unichem Laboratories said.

It is also used as an 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.

Unichem said the product will be commercialised from its Ghaziabad plant.