Alembic Pharmaceuticals receives USFDA final approval for Fenofibrate Tablets

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fenofibrate Tablets USP, 54 mg and 160 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Tricor Tablets, 54 mg and 160 mg, of AbbVie Inc. (AbbVie). Fenofibrate Tablets USP, 54 mg and 160 mg are indicated as an adjunct to diet to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidaemia and for treatment of adult patients with severe hypertriglyceridemia.

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