Alembic Pharmaceuticals announces USFDA Final Approval for Metolazone Tablets USP 2.5 mg, 5 mg, and 10 mg

Alembic Pharmaceuticals Limited (Alembic) 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 10 mg, of Lan nett 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.

Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.991 as compared to the previous close of Rs. 985.3. The total number of shares traded during the day was 12589 in over 1001 trades.

The stock hit an intraday high of Rs. 1005.25 and intraday low of 981.9. The net turnover during the day was Rs. 12513708.

Source : Equity Bulls

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