Alembic Pharma receives final US FDA approval for Chlorthalidone Tablets USP

The US Food and Drug Administration (FDA) has given the final approval to Alembic Pharma’s Abbreviated New Drug Application (ANDA) for Chlorthalidone Tablets USP, 25 mg and 50 mg.

The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Hygroton Tablets, 25 mg and 50 mg, of Sanofi. Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other anti-hypertensive 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. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis and chronic renal failure, the statement further said.

Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of $37 million for twelve months ending June 2022, according to IQVIA, the statement concluded.