Niaspan, Trilipix Labeling Revised to Remove Indication
The Food and Drug Administration (FDA) has approved a revision to the labeling for Niaspan (niacin extended-release tablets; Abbvie) and Trilipix (fenofibric acid capsules; Abbvie) to remove the indication for combined use of these agents with statins.
Niaspan is no longer indicated in combination with simvastatin or lovastatin for the treatment of primary hyperlipidemia and mixed dyslipidemia when treatment with Niaspan, simvastatin, or lovastatin monotherapy is considered inadequate.
Niaspan is currently indicated to reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia; to reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia; in combination with a bile acid binding resin to slow progression or promote regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia and as adjunct to diet to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia; and to reduce TG in adult patients with severe hypertriglyceridemia
Trilipix, a peroxisome proliferator-activated receptor alpha agonist, is no longer indicated as an adjunct to diet 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. Trilipix is currently indicated as adjunctive therapy to diet to reduce TG in patients with severe hypertriglyceridemia and reduce elevated LDL-C, Total-C, TG, and Apo B, and increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia.
For more information call (888) 463-6332 or visit FDA.gov.