FDA Updates Labels for Two Cholesterol-Lowering Agents
The US Food and Drug Administration (FDA) has approved an updated low-density lipoprotein (LDL)-cholesterol lowering indication for bempedoic acid (Nexletol) and the single-pill …
FDA Approves Label Update for Novartis’ Leqvio to Enable Twice …
Aug 1, 2025 · On July 10, 2023, the FDA approved a label update for the drug to enable earlier use in patients with elevated LDL-C who have an increased risk of heart disease, as an …
Labeling will change for two cholesterol-lowering medications
Jan 8, 2024 · Effective immediately, FDA has changed the labels on two medications used to bring down LDL cholesterol levels: bempedoic acid (Nexletol) and bempedoic acid/ezetimibe …
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Cholesterol Medicines This guide lists FDA-approved products currently available to treat high cholesterol levels and discusses the current approach to treating high cholesterol.
Inclisiran Receives FDA Approval for New Indication to Treat ...
Aug 1, 2025 · The FDA has approved a label update for inclisiran (Leqvio; Novartis Pharmaceuticals), allowing its use as monotherapy, in addition to diet and exercise, to reduce …
Cholesterol-lowering drugs get labeling changes | FDA
The U.S. Food and Drug Administration (FDA) recently approved labeling changes for statins to notify consumers about side effects and possible drug interactions related to the popular...
FDA Approves Label Update for Inclisiran as Monotherapy for ...
Aug 2, 2025 · The FDA has approved a label update for inclisiran (Leqvio), which can now be used as a monotherapy with diet and exercise to reduce low-density lipoprotein cholesterol …
Drug Safety-related Labeling Changes | FDA
Search the Drug Safety-related Labeling Changes (SrLC) database to obtain the most recent drug safety-related label changes, or read more about the SrLC database.
FDA Approves Updated LDL-C Lowering Indication for ... - Drug …
Dec 18, 2023 · The FDA approved an updated indication for Esperion’s bempedoic acid tablet (Nexletol) and bempedoic acid and ezetimibe tablet (Nexlizet) to include treatment of primary …
Important safety label changes to cholesterol-lowering statin drugs
The U.S. Food and Drug Administration (FDA) has approved important safety label changes for the class of cholesterol-lowering drugs known as statins.