October - December 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

… (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Prepopik (sodium picosulfate, magnesium oxide, and … is evaluating the need for regulatory action. Nexletol (bempedoic acid) Nexlizet (bempedoic acid and ezetimibe) Rhabdomyolysis FDA is …

October - December 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

…   Liptruzet (ezetimibe and atorvastatin) Nexlizet (bempedoic acid and ezetimibe) Roszet (rosuvastatin and ezetimibe) …   Liptruzet (ezetimibe and atorvastatin) Nexlizet (bempedoic acid and ezetimibe) Roszet (rosuvastatin and …

Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act

… 3/31/23 5/10/23   Esperion Therapeutics, Inc.  Nexletol (bempedoic acid) tablets and Nexlizet (bempedoic acid and ezetimibe) tablets 11/21/22 12/26/22   …

Cholesterol Medicines Guide

… and Cholesterol-Lowering Combination Medicines Omega-3-Acid Ethyl Esters Bile Acid Sequestrants Fibric Acid … Lyase (ACL) Inhibitors Generic Name Brand Name bempedoic acid Nexletol ACL Inhibitors: What You Should Know … Medicines Generic Name Brand Name ezetimibe and bempedoic acid Nexlizet ezetimibe and rosuvastatin Roszet …

January - March 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

… is evaluating the need for regulatory action. Nexletol (bempedoic acid)   Hypersensitivity FDA is evaluating the need for …

Drug Trials Snapshots: NEXLETOL

… Information for complete information. NEXLETOL (bempedoic acid) nex' leh tol Esperion Approval date: February 21, 2020 … side effects including tendon rupture, and high uric acid levels in the blood. The most common side effects of …

List of Pregnancy Exposure Registries

…     Phone: 1-844-734-6643 Ongoing   Nexletol; Nexlizet (bempedoic acid) High cholesterol [heterozygous familial … atherosclerotic cardiovascular disease (ASCVD)] Bempedoic Acid Pregnancy Surveillance Program Phone: +1 833 …

Table of Pharmacogenomic Biomarkers in Drug Labeling

… Use in Specific Populations, Clinical Studies   Ascorbic Acid Endocrinology G6PD Dosage and Administration, Warnings … in Specific Populations, Clinical Pharmacology   Ascorbic Acid, PEG-3350, Potassium Chloride, Sodium Ascorbate, Sodium …   Belzutifan (3) Oncology VHL Clinical Studies   Bempedoic Acid and Ezetimibe Endocrinology Nonspecific …

Drug Trials Snapshots

… or metastatic breast cancer. Cerianna CHOLBAM  cholic acid March 17, 2015 Treatment of bile acid synthesis disorders due to single enzyme defects  … positive neuro-endocrine tumors (NETs) Netspot NEXLETOL bempedoic acid February 21, 2020 Treatment of high LDL …

New Drug Application (NDA) and Biologic License Application (BLA) Efficacy Supplement Calendar Year Approvals: 2024

… USA INC P 3/19/2024 NDA 211616 12 New Indication NEXLETOL (BEMPEDOIC ACID) ESPERION THERAPEUTICS INC S 3/22/2024 NDA 211616 13 New Indication NEXLETOL (BEMPEDOIC ACID) ESPERION THERAPEUTICS INC S 3/22/2024 NDA …

Nexletol Prea Non-compliance Letter 11-18-22

… Food, Drug, and Cosmetic Act (the Act) for Nexletol (bempedoic acid) tablets (NDA 211616), which was approved on February 21, 2020, and Nexlizet (bempedoic acid and ezetimibe) tablets (NDA 211617), which was …

Opening Comments September 19, 2021 Meeting of the Pediatric Advisory Committee

… capsules 11/17/22 Esperion Therapeutics, Inc Nexletol (bempedoic acid) tablets 11/21/22 Esperion Therapeutics, Inc Nexlizet (bempedoic acid and ezetimibe) tablets 11/21/22 Salix …

CDER Drug and Biologic Approvals for Calendar Year 2020

… MELOXICAM BAUDAX BIO INC S Y 2/20/2020 NDA 211616 NEXLETOL BEMPEDOIC ACID ESPERION THERAPEUTICS INC S 2/21/2020 NDA 209510 … ACACIA PHARMA LTD S Y 2/26/2020 NDA 211617 NEXLIZET BEMPEDOIC ACID AND EZETIMIBE ESPERION THERAPEUTICS INC S Y …

FY 2022 Q2 Real Time Report - Generic Drugs

… G_019389.pdf 11/8/2021 Other N/A 7 Q1 Bempedoic Acid; Draft Guidance for Industry … G_211616.pdf 11/8/2021 Other N/A 8 Q1 Bempedoic Acid; Ezetimibe; Draft Guidance for Industry …

FY 2022 Q1 Real Time Report - Generic Drugs

… G_019389.pdf 11/8/2021 Other N/A 7 Q1 Bempedoic Acid; Draft Guidance for Industry … G_211616.pdf 11/8/2021 Other N/A 8 Q1 Bempedoic Acid; Ezetimibe; Draft Guidance for Industry …

Cholesterol Medicines Guide PDF

… and Cholesterol-Lowering Combination Medicines • Omega-3-Acid Ethyl Esters • Bile Acid Sequestrants • Fibric Acid … Lyase (ACL) Inhibitors Generic Name Brand Name bempedoic acid Nexletol For the most complete and up-to-date … Medicines Generic Name Brand Name ezetimibe and bempedoic acid Nexlizet Roszetezetimibe and rosuvastatin …

New Paragraph IV Certifications

… mg and 300 mg Onureg 214120 9/30/2021 1 6/3/2030 Azelaic Acid Gel 15% Finacea 21470 7/27/2012 1 Extinguished 2/11/2020 … 500 mg/vial Beleodaq 206256 7/3/2018 1 10/27/2027 Bempedoic Acid Tablets 180 mg Nexletol 211616 2/21/2024 9 … MARKETING BY FTF EXPIRATION DATE OF LAST QUALIFYING PATENT Bempedoic Acid and Ezetimibe Tablets 180 mg/10 mg Nexlizet …

FY 2022 Q4 Real Time Report - Generic Drugs

… G_019389.pdf 11/8/2021 Other N/A 7 Q1 Bempedoic Acid; Draft Guidance for Industry … G_211616.pdf 11/8/2021 Other N/A 8 Q1 Bempedoic Acid; Ezetimibe; Draft Guidance for Industry …

FY 2022 Q3 Real Time Report - Generic Drugs

… G_019389.pdf 11/8/2021 Other N/A 7 Q1 Bempedoic Acid; Draft Guidance for Industry … G_211616.pdf 11/8/2021 Other N/A 8 Q1 Bempedoic Acid; Ezetimibe; Draft Guidance for Industry …

February 2020: Additions and Deletions to the Drug Product List

… 100MG A210215 001 Mar 10, 2020 Feb NEWA AMINOCAPROIC ACID SYRUP;ORAL AMINOCAPROIC ACID > A> AA VISTAPHARM … GLAND PHARMA LTD 0.05% A210092 001 Feb 25, 2020 Feb NEWA BEMPEDOIC ACID> A> TABLET;ORAL> A> NEXLETOL> A> > A> +! … THERAPS INC 180MG N211616 001 Feb 21, 2020 Feb NEWA BEMPEDOIC ACID; EZETIMIBE> A> TABLET;ORAL> A> NEXLIZET> A> > …

FDA EPC Text Phrases for Indications and Usage heading in Highlights (updated February 2022)

… receptor agonist REGADENOSON adenosine receptor agonist BEMPEDOIC ACID adenosine triphosphate-citrate lyase (ACL) inhibitor … alpha glucosidase inhibitor AMMONIUM LACTATE alpha hydroxy acid PEGINTERFERON ALFA-2B alpha interferon RADIUM RA-223 …

FDA EPC Text Phrases for Indications and Usage heading in Highlights (updated October 2021)

… agonist REGADENOSON ANHYDROUS adenosine receptor agonist BEMPEDOIC ACID adenosine triphosphate-citrate lyase (ACL) inhibitor … alpha glucosidase inhibitor AMMONIUM LACTATE alpha hydroxy acid RADIUM RA-223 CATION alpha particle-emitting radioactive …

FDA EPC Text Phrases for Highlights Indications and Usage heading

… receptor agonist REGADENOSON adenosine receptor agonist BEMPEDOIC ACID adenosine triphosphate-citrate lyase (ACL) inhibitor … alpha glucosidase inhibitor AMMONIUM LACTATE alpha hydroxy acid PEGINTERFERON ALFA-2B alpha interferon RADIUM RA-223 …

FDA EPC Text Phrases for Highlights Indications and Usage heading (updated December 2023)

… receptor agonist REGADENOSON adenosine receptor agonist BEMPEDOIC ACID adenosine triphosphate-citrate lyase (ACL) inhibitor … alpha glucosidase inhibitor AMMONIUM LACTATE alpha hydroxy acid PEGINTERFERON ALFA-2B alpha interferon RADIUM RA-223 …

FDA EPC Text Phrases for Highlights Indications and Usage heading (updated June 2022)

… receptor agonist REGADENOSON adenosine receptor agonist BEMPEDOIC ACID adenosine triphosphate-citrate lyase (ACL) inhibitor … alpha glucosidase inhibitor AMMONIUM LACTATE alpha hydroxy acid PEGINTERFERON ALFA-2B alpha interferon PEGINTERFERON …