fluvastatin sodium
fluvastatin sodium is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand names including FLUVASTATIN SODIUM ER, Lescol XL. Available dosage form: tablet, extended release.
Drug Details
- Generic Name
- fluvastatin sodium
- Brand Names
- FLUVASTATIN SODIUM ER, Lescol XL
- Application Number
- NDA021192
- Sponsor
- Sandoz Inc
- NDC Codes
- 2
- Dosage Forms
- TABLET, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- FLUVASTATIN SODIUM
Indications and Usage
1 INDICATIONS AND USAGE 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. 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