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Drug firm Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator for Metolazone tablets, indicated for the treatment of salt and water retention caused by heart failure or kidney disease.
The approved product is therapeutically equivalent to the reference listed drug product Zaroxolyn Tablets 2.5 mg, 5 mg and 10 mg of Lannett Company, Inc.
In a regulatory filing, Alembic Pharmaceuticals said "it has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Metolazone tablets USP 2.5 mg, 5 mg, and 10 mg".
Metolazone tablets are indicated for the treatment of salt and water retention including edema accompanying congestive heart failure, edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function.
Metolazone tablets are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class.
Quoting IQVIA data, Alembic Pharma said Metolazone tablets USP 2.5 mg, 5 mg, and 10 mg have an estimated market size of USD 33 million for 12 months ending September 2020.
Alembic Pharma has a cumulative total of 137 ANDA approvals (118 final approvals and 19 tentative approvals) from USFDA.
