FDA gives Alembic permission for generic Hygroton

Alembic has obtained the Food and Drug Administration‘s nod for chlorthalidone tablets in dosage strengths of 25 mg and 50 mg.

The product is the generic of Sanofi Aventis’s Hygroton.

[Read more: Alembic intros generic Perforomist]

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. It also has been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis and chronic renal failure.

[Read more: Alembic obtains FDA nod for 2 generics]

Chlorthalidone tablets had a market value of roughly $37 million for the 12 months ending June 2022 according to IQVIA.