The Food and Drug Administration (FDA) is withdrawing approval of the indications for niacin extended-release (ER) tablets and fenofibric acid delayed-release (DR) capsules related to the coadministration of these agents with statins.
The notice states that “based on the collective evidence from several large cardiovascular outcome trials, the Agency has concluded that the totality of the scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events. Consistent with this conclusion, FDA has determined that the benefits of niacin ER tablets and fenofibric acid DR capsules for coadministration with statins no longer outweigh the risks, and the approvals for this indication should be withdrawn.”
The affected products include Niaspan (niacin extended-release tablets; Abbvie), Trilipix (fenofibric acid delayed-release capsules; Abbvie), as well as the approved generics and any applications that are currently in the pipeline for approval. Combination products such as Advicor (niacin extended-release, lovastatin; Abbvie) and Simcor (niacin extended-release, simvastatin; Abbvie) were also discontinued by the manufacturer with distribution of the product ending on December 31st, 2015. The FDA requested manufacturers stop marketing niacin ER tablets and fenofibric acid DR capsules for these indications.
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 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 visit FederalRegister.gov.