Last Updated on November 5, 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.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.
USFDA approval granted for generic Cetirizine tablets
USFDA approval granted for Lamotrigine Extended-Release Tablets USP
USFDA approval granted for Cephalexin tablets
USFDA approval granted for Paliperidone extended-release Tablets
First USFDA approval granted for Lidocaine Hydrochloride Injection: Aurobindo
USFDA approval granted for Albendazole Tablets USP, 200 mg: Alembic
Gujarat FDCA empowers Officers to enforce Revised Schedule M
Govt asks NPPA to recalculate ceiling price of Thiamine Injection
DTAB recommends changes to New Drugs and Clinical Trials Rules
NPPA revised Ceiling price of 11 scheduled formulations: October 2024
New Drugs, Medical Devices and Global Standards: India’s Regulatory Advancements
NPPA fixed retail price of 20 formulations: October 2024
19th ICDRA – Day 2nd: Key Highlights from the Workshop
Drug recall: Glenmark recalls drugs for manufacturing issues
Drug Regulatory System of India gains Global Recognition
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
