Alembic Pharmaceuticals receives USFDA final nod for Chlorthalidone Tablets USP

Alembic Pharmaceuticals receives USFDA final nod for Chlorthalidone Tablets USP

by admin- Monday, August 29th, 2022 03:01:22 PM

 

Alembic Pharmaceuticals acquired very last 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 authorised ANDA is therapeutically equal to the reference listed drug product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US. LLC (Sanofi). Diuretics which include chlorthalidone are indicated in the management of hypertension both as the sole therapeutic agent or ; to enhance the effect of different antihypertensive drugs in the greater excessive kinds of high blood pressure. Chlorthalidone is indicated as adjunctive therapy in edema related to congestive coronary heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has additionally been discovered useful in edema due to diverse forms of renal dysfunction, inclusive of nephrotic syndrome, acute glomerulonephritis, and continual renal failure.

Chlorthalidone Tablets USP, 25 mg and 50 mg, have an envisioned market length of US$ 37 million for 12 months finishing June, 2022 in step with IQVIA.
Alembic has.A cumulative general of 171 ANDA approvals (147 final approvals and 24 tentative approvals) from USFDA.

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