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Lupin receives US FDA approval for Fenofibrate tabs

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Lupin Pharmaceuticals would commence promoting the product shortly in the US

Lupin has received final approval for its Fenofibrate tablets 54 mg and 160 mg from the United States Food and Drugs Administration (US FDA) to market a generic version of Teva’s Fenofibrate tablets, 54 mg and 160 mg. Lupin’s US subsidiary, Lupin Pharmaceuticals would commence promoting the product shortly in the US.

Lupin’s Fenofibrate tablets 54 mg and 160 mg is the AB rated generic equivalent of the current reference listed drug, Fenofibrate tablets 54 mg and 160 mg of Teva. It is 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 dyslipidemia and for treatment of adult patients with severe hypertriglyceridemia.

Fenofibrate tablets 54 mg and 160 mg has US sales of $156 million.

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