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PITTSBURGH — Mylan Inc. has released fenofibrate tablets, a treatment for high cholesterol and triglycerides, in strengths of 48 mg and 145 mg.
The company said Friday that its Mylan Pharmaceuticals Inc. subsidiary received final approval from the Food and Drug Administration for the product, which is a generic version of AbbVie Inc.’s Tricor Tablets.
Fenofibrate tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. Fenofibrate Tablets also are indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia.
Fenofibrate Tablets, 48 mg and 145 mg, had U.S. sales of approximately $1.2 billion for the 12 months ending March 31, 2013, according to IMS Health.
