Alembic Pharmaceuticals Limited (Alembic) today announced it has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Metolazone Tablets USP 2.5 mg, 5 mg, and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Zaroxolyn Tablets 2.5 mg, 5 mg, and 1 O mg, of Lannett Company, Inc. Metolazone Tablets are indicated for the treatment of salt and water retention including: a) edema accompanying congestive heart failure; b) 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. Metolazone Tablets USP 2.5 mg, 5 mg, and 10 mg have an estimated market size of US$ 33 million for twelve months ending September 2020 according to IQVIA. Alembic has a cumulative total of 137 ANDA approvals (118 final approvals and 19 tentative approvals) from USFDA.