Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 212028
Company: EISAI INC
Company: EISAI INC
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 |
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) |
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) |