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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, 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.
Tricor tablets and generic equivalents had US sales of approximately $307 million 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.
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