Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Fludrocortisone Acetate Tablets USP, 0.1 mg (USRLD: Florinef Tablets, 0.1 mg).
Fludrocortisone acetate tablets are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome. Fludrocortisone acetate tablets will be produced at the Group's manufacturing site at Moraiya, Ahmedabad.
Fludrocortisone acetate tablets had annual sales of USD 19.9 mn in the United States (IQVIA MAT July 2024).