← FDA DRUG APPROVALS

FDA NDA · NDA212028

DAYVIGO

lemborexant

Sponsor: EISAI INC

APPLICATION
NDA212028
TYPE
NDA
ORIGINAL APPROVAL
2019-12-20
LATEST ACTION
2025-02-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DAYVIGO · ReferencePrescription
LEMBOREXANT 10MG · TABLET · ORAL
DAYVIGO · ReferencePrescription
LEMBOREXANT 5MG · TABLET · ORAL

Approval history

2025-02-19Labeling · Supplement 11 · standard — Label ↗AP
2023-04-20Efficacy · Supplement 8 · standard — Letter ↗AP
2023-01-25Labeling · Supplement 7 · standard — Letter ↗AP
2022-03-11Labeling · Supplement 6 · standard — Letter ↗AP
2020-08-25Labeling · Supplement 2 · standard — Letter ↗AP
2019-12-20Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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