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29th August 2022, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its 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 product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US LLC (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 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. 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.
Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of US$ 37 million for twelve months ending June, 2022 according to IQVIA.
Alembic has a cumulative total of 171 ANDA approvals (147 final approvals and 24 tentative approvals) from USFDA.