Unichem Laboratories gets FDA approval hypertension management drug

Unichem Lab gets FDA approval for hypertension management drug

9:14 AM, 12th August 2019
Unichem Laboratories logo

MUMBAI, INDIA: Unichem Laboratories Limited has received abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) for its Chlorthalidone tablets, used to treat hypertension.

The approved product is a generic version of Hygroton tablets of Sanofi Aventis US LLC.

The Chlorthalidone tablets are 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 used as an adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. In addition, for 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, Uttar Pradesh plant.

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