Application Nr Approved Date Route Status External Links
NDA211617 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Nexlizet Is Indicated As An Adjunct To Diet And Maximally Tolerated Statin Therapy For The Treatment Of Adults With Heterozygous Familial Hypercholesterolemia Or Established Atherosclerotic Cardiovascular Disease Who Require Additional Lowering Of Ldl-C. Nexlizet, Which Contains An Adenosine Triphosphate-Citrate Lyase (Acl) Inhibitor And A Cholesterol Absorption Inhibitor, Is Indicated As An Adjunct To Diet And Maximally Tolerated Statin Therapy For The Treatment Of Adults With Heterozygous Familial Hypercholesterolemia Or Established Atherosclerotic Cardiovascular Disease Who Require Additional Lowering Of Ldl-C. ( 1 ) Limitations Of Use : The Effect Of Nexlizet On Cardiovascular Morbidity And Mortality Has Not Been Determined. ( 1 ) Limitations Of Use The Effect Of Nexlizet On Cardiovascular Morbidity And Mortality Has Not Been Determined.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Bempedoic Acid
2. Ezetimibe EZETIMIBE ZINC3810860

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