Par Pharmaceutical receives final ANDA approval for generic version of Trilipix

Jul 19 2013

Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for fenofibric acid EQ 45 mg and EQ 135 mg delayed-release (DR) capsules. Fenofibric acid DR is the generic version of AbbVie's Trilipix^® and is indicated: in combination with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal; as monotherapy to reduce TG in patients with severe hypertriglyceridemia; and as monotherapy to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia. 

Par has begun shipping all approved strengths of the product.  According to IMS Health data, annual U.S. sales of Trilipix^® are approximately $554 million.