Cipla receives ANDA approval for Fenofibrate Tablets

From USFDA

Cipla 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.

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