FDA Approves Fenofibrate Product for Treating Certain Cholesterol Conditions

Officials with the FDA have approved Alembic Pharmaceuticals’ Fenofibrate Tablets USP, 48 mg and 145 mg as an adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B).

The newly approved product is the therapeutic equivalent to AbbVie’s Tricor Tablets, 48 mg and 145 mg.

The drug also is indicated for increasing high-density lipoprotein cholesterol (HDLC) in adult patients with primary hypercholesterolemia or mixed dyslipidemia, as well as use as an adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia.

Improving glycemic control in individuals with diabetes showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention, according to Alembic. Markedly elevated levels of serum triglycerides (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 adequately studied.

Reference

Alembic Pharmaceuticals receives USFDA Approval for Fenofibrate Tablets USP, 48 mg and 145 mg [news release]. Vadodara, India; August 13, 2019: Alembic website. https://www.alembicpharmaceuticals.com/wp-content/uploads/2019/08/Press-Release-USFDA-Approval-Fenofibrate-Tablets-USP-48-mg-and-145-mg-August-2019.pdf. Accessed August 2019.