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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 …
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 …
Novel Drug Approvals for 2020
… 6/30/2020 To treat molecularly long-chain fatty acid oxidation disorders Drug Trials Snapshot 24. Zepzelca … of migraine in adults Drug Trials Snapshot 5. Nexletol bempedoic acid 2/21/2020 To treat adults with heterozygous familial …
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 …
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 Therapy Approvals 2020
… To treat molecularly confirmed long-chain fatty acid oxidation disorders Oral Liquid 12/21/20 Ebanga … diffuse large B-cell lymphoma Injection 02/21/20 Nexletol bempedoic acid To treat adults with heterozygous familial …
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 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 …
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 …
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 …
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 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 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 …
CDER New Molecular Entity (NME) and Original Biologic Approvals Calendar Year 2020
… CONSTIPATION (CIC) IN ADULTS NDA 211616 NEXLETOL BEMPEDOIC ACID ESPERION THERAPEUTICS INC S 2/21/2020 FOR THE TREATMENT … ADULT PATIENTS WITH MOLECULARLY CONFIRMED LONG-CHAIN FATTY ACID OXIDATION DISORDERS (LC-FAOD). NDA 212295 BYFAVO …
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 Indications and Usage Heading in Highlights (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 …
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 …