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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211617
Company: ESPERION THERAPS INC

Products on NDA 211617

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NEXLIZET	BEMPEDOIC ACID; EZETIMIBE	180MG;10MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211617

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/26/2020	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211617s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211617Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/211617Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2023	SUPPL-19	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211617s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211616Orig1s015; 211617Orig1s019ltr.pdf
09/20/2023	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211617s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211616Orig1s014;211617Orig1s018ltr.pdf
03/22/2024	SUPPL-17	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211617s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211617Origs016; s017ltr.pdf
03/22/2024	SUPPL-16	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211617s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211617Origs016; s017ltr.pdf

Labels for NDA 211617

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/22/2024	SUPPL-17	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211617s016s017lbl.pdf
03/22/2024	SUPPL-16	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211617s016s017lbl.pdf
12/13/2023	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211617s019lbl.pdf
12/13/2023	SUPPL-19	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211617s019lbl.pdf
09/20/2023	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211617s018lbl.pdf
02/26/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211617s000lbl.pdf

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