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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 evaluating the need for …
Cholesterol Medicines Guide
… and Cholesterol-Lowering Combination Medicines Omega-3-Acid Ethyl Esters Bile Acid Sequestrants Fibric Acid … Cholesterol Absorption Inhibitors Generic Name Brand Name ezetimibe Zetia Cholesterol Absorption Inhibitors: What You … Lyase (ACL) Inhibitors Generic Name Brand Name bempedoic acid Nexletol ACL Inhibitors: What You Should Know …
Cholesterol Medicines Guide PDF
… and Cholesterol-Lowering Combination Medicines • Omega-3-Acid Ethyl Esters • Bile Acid Sequestrants • Fibric Acid … Cholesterol Absorption Inhibitors Generic Name Brand Name ezetimibe Zetia For the most complete and up-to-date … Lyase (ACL) Inhibitors Generic Name Brand Name bempedoic acid Nexletol For the most complete and up-to-date …
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 Pharmaceuticals Inc …
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 … LTD S Y 2/26/2020 NDA 211617 NEXLIZET BEMPEDOIC ACID AND EZETIMIBE ESPERION THERAPEUTICS INC S Y 2/26/2020 NDA 212728 …
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> +! … 180MG N211616 001 Feb 21, 2020 Feb NEWA BEMPEDOIC ACID; EZETIMIBE> A> TABLET;ORAL> A> NEXLIZET> A> > A> +! ESPERION …
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… G_019389.pdf 11/8/2021 Other N/A 7 Q1 Bempedoic Acid; Draft Guidance for Industry … G_211616.pdf 11/8/2021 Other N/A 8 Q1 Bempedoic Acid; Ezetimibe; Draft Guidance for Industry …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 …
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 …
FDA EPC Text Phrases for Indications and Usage Heading in Highlights (updated July 2023)
… receptor agonist REGADENOSON adenosine receptor agonist BEMPEDOIC ACID adenosine triphosphate-citrate lyase (ACL) inhibitor … dye BEDAQUILINE diarylquinoline antimycobacterial EZETIMIBE dietary cholesterol absorption inhibitor …
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 … dye BEDAQUILINE diarylquinoline antimycobacterial EZETIMIBE dietary cholesterol absorption inhibitor …
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 … dye BEDAQUILINE diarylquinoline antimycobacterial EZETIMIBE dietary cholesterol absorption inhibitor …
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 … dye BEDAQUILINE diarylquinoline antimycobacterial EZETIMIBE dietary cholesterol absorption inhibitor …
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 … dye BEDAQUILINE diarylquinoline antimycobacterial EZETIMIBE dietary cholesterol absorption inhibitor …