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. The tablets will be produced at the Group’s manufacturing site in Moraiya, Ahmedabad.
Fludrocortisone acetate tablets had annual sales of $ 19.9 mn in the United States (IQVIA MAT July 2024).
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