Mylan Unveils Generic Fenoglide Tablets

(RTTNews) - Mylan N.V. (MYL) 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 or 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.

Currently, Mylan has 246 ANDAs pending FDA approval representing $107.4 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $37.2 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.