Last Updated on December 21, 2024 by The Health Master
USFDA approval
Zydus Lifesciences has received final United States Food and Drug Administration approval (USFDA approval) to manufacture Fludrocortisone Acetate Tablets USP, 0.1 mg (USRLD: Florinef Tablets, 0.1 mg).
What is Fludrocortisone Acetate?
Fludrocortisone acetate is a synthetic corticosteroid that is used to treat adrenal insufficiency.
Adrenal insufficiency is a condition in which the adrenal glands do not produce enough cortisol, a hormone that is essential for life.
Uses of Fludrocortisone Acetate Tablets
Fludrocortisone acetate tablets are indicated for the following uses:
- Partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison’s disease
- Treatment of salt-losing adrenogenital syndrome
How Fludrocortisone Acetate Tablets Work
Fludrocortisone acetate tablets work by replacing the cortisol that the adrenal glands are not producing. Cortisol is a hormone that helps to regulate the body’s metabolism, blood pressure, and immune system.
Zydus Lifesciences Manufacturing Site
The tablets will be produced at the Group’s manufacturing site in Moraiya, Ahmedabad.
Market Size of Fludrocortisone Acetate Tablets
Fludrocortisone acetate tablets had annual sales of $ 19.9 mn in the United States (IQVIA MAT July 2024).
Zydus Lifesciences has received final USFDA approval to manufacture Fludrocortisone Acetate Tablets USP, 0.1 mg.
This is good news for patients with adrenal insufficiency, as it will increase the availability of this important medication.
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