Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212028
Company: EISAI INC

• Medication Guide

Products on NDA 212028

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DAYVIGO	LEMBOREXANT	5MG	TABLET;ORAL	Prescription	None	Yes	No
DAYVIGO	LEMBOREXANT	10MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212028

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
12/20/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Federal Register Notice Label (PDF) Letter (PDF) Review	FR Notice on DEA Scheduling; Date of Approval – April 7, 2020

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
04/20/2023	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)
01/25/2023	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)
03/11/2022	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)
08/25/2020	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)

Labels for NDA 212028

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
04/20/2023	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)
01/25/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)
03/11/2022	SUPPL-6	Labeling-Package Insert	Label (PDF)
08/25/2020	SUPPL-2	Labeling-Package Insert	Label (PDF)
12/20/2019	ORIG-1	Approval	Label (PDF)