Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Medical Devices | Videos
Drug Research
Drug Delivery
Return to: PBR Home | Drug Research | Drug Delivery

Mylan launches generic Fenoglide tablets in US

Published 07 July 2016

Mylan announced the US 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.

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.



Source: Company Press Release