Mylan is releasing a generic version of Santarus' fenofibrate (Fenoglide) tablets.
Mylan is releasing a generic version of Santarus’ fenofibrate (Fenoglide) tablets.
The FDA approved the manufacturer’s abbreviated new drug application for the 40-mg and 120-mg tablets on July 6, 2016.
The product may be used as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol, total cholesterol, triglycerides, and apolipoprotein B and to increase high-density lipoprotein in adult patients with primary hypercholesterolemia or mixed dyslipidemia.
In the year ending April 30, 2016, fenofibrate tablets had US sales of around $28.6 million, IMS Health reported.
Mylan hopes to receive FDA approval for nearly 250 additional abbreviated new drug applications still pending.