Fenofibric acid
Fenofibric acid is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand name including Fenofibric acid. Available dosage form: capsule, delayed release.
Drug Details
- Generic Name
- Fenofibric acid
- Brand Names
- Fenofibric acid
- Application Number
- ANDA213450
- Sponsor
- Micro Labs Limited
- NDC Codes
- 6
- Dosage Forms
- CAPSULE, DELAYED RELEASE
- Routes
- ORAL
- Active Ingredients
- FENOFIBRIC ACID, CHOLINE FENOFIBRATE
Indications and Usage
1 INDICATIONS & USAGE Fenofibric acid delayed-release capsules is indicated as adjunctive therapy to diet: • to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). • to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. Limitations of Use • Markedly elevated levels of serum TG (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined [see Warnings and Precautions ( 5.7 )]. • Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions ( 5.1 ) and Clinical Studies ( 14.4 )]. Fenofibric acid delayed-release capsules are a peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunct to diet: • to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL) ( 1 ). • to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible ( 1 ). Limitations of Use: • Markedly elevated levels of serum TG (e.g., >2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been determined ( 1 ). • Fenofibrate did not reduce coronary heart disease morbidity and mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus ( 1 ).