WOODCLIFF LAKE, N.J., July 18, 2013 /PRNewswire/ -- 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.
Important Information About Fenofibric Acid DR Capsules
Fenofibric acid delayed-release capsules are contraindicated in: patients with severe renal impairment, including those receiving dialysis; patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities; patients with preexisting gallbladder disease; nursing mothers; and patients with hypersensitivity to fenofibric acid or fenofibrate.
About Par Pharmaceutical Companies, Inc.
Par Pharmaceutical Companies, Inc. is a privately held, U.S.-based specialty pharmaceutical company that develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals. For press release and other company information, visit www.parpharm.com.
SOURCE Par Pharmaceutical Companies, Inc.