U.S. FDA Updates LDL-C Lowering Indication for Esperion ’s Nexletol (bempedoic acid) Tablet and Nexlizet (bempedoic acid and ezetimibe) Tablet

Updated Label Adds Primary Hyperlipidemia, Removes Maximally Tolerated Statin Requirement, Removes Limitation of Use Cardiovascular (CV) Risk Reduction Labels Remain on Track: in U.S. with PDUFA Date of March 31; in Europe with Anticipated...
Source: Drugs.com - New Drug Approvals - Category: Drugs & Pharmacology Source Type: news