Business Standard: December 19, 2016
Mumbai: The US Food and Drugs Administration (FDA) has granted final approval for Cipla Ltd’s for its abbreviated new drug application (ANDA) for fenofibrate tablet (48 mg and 145 mg).
Fenofibrate tablet, the generic equivalent of AbbVie’s Tricor tablet, is 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.
Tricor tablet and generic equivalents had US sales of approximately $ 307 million for the 12 month period ending October 2016, according to IMS Health.
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