East Windsor, N.J. – Aurobindo Pharma Limited 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 Inc.’s TRILIPIX®.

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*.

*IMS National Sales Perspectives: Retail and Non-Retail MAT June 2019