What is the generic name?

FENOFIBRIC ACID

What is the Trade Name for FENOFIBRIC ACID?

FIBRICOR

What are the Indications for FENOFIBRIC ACID?

• 1 INDICATIONS AND USAGE FIBRICOR is a peroxisome proliferator receptor alpha (PPARŒ±) activator indicated as an adjunct to diet: to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (‚â• 500 mg/dL) ( 1.1 ). to reduce elevated total cholesterol (TC), low-density-lipoprotein cholesterol (LDL-C), TG and apolipoprotein (Apo) B and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia ( 1.2 ). Important Limitations of Use: Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus ( 1.3 ). 1.1 Severe Hypertriglyceridemia FIBRICOR is indicated as adjunctive therapy to diet for treatment of severe hypertriglyceridemia (‚â• 500 mg/dL). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides > 2000 mg/dL may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. 1.2 Primary Hypercholesterolemia or Mixed Dyslipidemia FIBRICOR is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia. 1.3 Important Limitations of Use Fenofibrate at a dose equivalent to 105 mg of FIBRICOR was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus [ see Warnings and Precautions (5.1) ].

References: https://open.fda.gov/