FDA approves Mylan's ANDA for Fenofibrate Tablets

May 17 2013

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has shipped Fenofibrate Tablets, 48 mg and 145 mg. Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is the 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 at a dose equivalent to 145 mg has not been shown to reduce coronary heart disease morbidity and mortality in a controlled trial of patients with type 2 diabetes mellitus.

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.

Currently, Mylan has 178 ANDAs pending FDA approval representing $83.1 billion in annual sales, according to IMS Health.  Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $22.4 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.