Cipla Ltd, a global pharmaceutical company has received final approval for its Abbreviated New Drug Application (ANDA) for Fenofibrate Tablets USP 48mg and 145mg, from the United States Food and Drug Administration (USFDA).
Fenofibrate Tablets are AB-rated generic
Fenofibrate Tablets, USP 48mg and 145mg, are AB-rated generic equivalents of AbbVie’s Tricor tablets and are indicated as adjunctive therapy to diet to reduce elevated low-density lipoproteincholesterol (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.
US sales of approximately $307M
Tricor Tablets and generic equivalents had US sales of approximately $307M for the 12 month period ending October 2016, according to IMS Health. Cipla’s Fenofibrate Tablets will be available for commercial shipment in the US in the coming weeks.
Cipla, a global pharmaceutical company
Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. In the last 80+ years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla portfolio includes over 1000 products across wide range of therapeutic categories with one quality standard globally.