Aurobindo gets FDA approval for fenofibric acid delayed-release capsules

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EAST WINDSOR, N.J. – Aurobindo has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application for fenofibric acid delayed-release capsules, 45 mg and 135 mg. Aurobindo’s fenofibric acid delayed-release capsules is an AB-rated generic equivalent to the reference listed drug, Abbvie’s Trilpix.

Fenofibric acid delayed-release capsules are peroxisome proliferator-activated receptor (PPAR) alpha agonist indicated as adjunctive therapy to diet to:

• Reduce TG in patients with severe hypertriglyceridemia

• Reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in patients with primary

Fenofibric acid delayed-release capsules has an estimated market size of $42M for the twelve months ending June 2019 according to IMS.


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