Alembic Pharma gets USFDA nod for BP drug

Alembic Pharmaceuticals on Monday said it has received an approval from the US health regulator for chlorthalidone tablets, used in treating high blood pressure.

The company has received final approval from the US Food and Drug Administration (USFDA) to market the product in the US in strengths of 25 mg and 50 mg, the drug maker said in a statement.

Alembic's product is therapeutically equivalent to Sanofi Aventis' Hygroton tablets. Diuretics such as chlorthalidone are 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.

Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.

The product has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.

According to IQVIA, chlorthalidone tablets had an estimated market size of USD 37 million for 12 months ended June 2022.