Aurobindo receives FDA approval for fenofibrate capsules

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EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application fenofibrate capsules USP, 67mg, 134mg, and 200mg. Aurobindo Pharma’s fenofibrate capsules USP, 67mg, 134mg, and 200mg are an AB-rated generic equivalent to the reference listed drug (RLD), Tricor Capsules of AbbVie.

Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). It is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia).

Fenofibrate capsules has an estimated market size of US $13.1 Million for the twelve months ending July 2021, as per IQVIA.


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