Mylan has announced the U.S. launch of Fenofibrate Tablets USP, 40 mg and 120 mg, which is a generic version of Santarus's Fenoglide®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol, total cholesterol, Triglycerides, and apolipoprotein B to increase high-density lipoprotein in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
Fenofibrate Tablets USP, 40 mg and 120 mg, had U.S. sales of approximately $28.6 million for the 12 months ending April 30, 2016, according to IMS Health.