Lowers the risk of undergoing coronary revascularization procedures and slow the…. ANDA 209397, held by Beijing. Fluvastatin Sodium.
As of Nov 15, 2026, ANDA 209397 (Fluvastatin Sodium), held by Beijing, was first approved by FDA on Apr 26, 2021, with 1 approved supplement and 0 published complete response letters.
Fluvastatin sodium extended-release tablets are indicated: To reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis in adults with clinically evident coronary heart disease. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. As an adjunct to diet to reduce LDL-C in adults and pediatric patients 10 years of age and older with heterozygous familial hypercholesterolemia (HeFH) who require 80 mg of fluvastatin daily.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 26, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluvastatin SodiumEQ 80MG BASE · tablet, extended release;oral | Fluvastatin Sodium | Rx |
| Jul 11, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Apr 26, 2021 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
