NDA 212028

EISAI INC

FDA Drug Application

Application #212028

Documents

• Label: 2019-12-23
• Medication Guide: 2019-12-23
• Letter: 2019-12-26
• Review: 2020-01-28
• Letter: 2020-08-25
• Label: 2020-09-01
• Federal Register Notice: 2021-10-08
• Letter: 2022-03-14
• Label: 2022-03-15
• Medication Guide: 2022-03-15
• Letter: 2023-01-26
• Label: 2023-01-30
• Medication Guide: 2023-01-30

Application Sponsors

NDA 212028

EISAI INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	2	DAYVIGO	LEMBOREXANT
002	TABLET;ORAL	10MG	2	DAYVIGO	LEMBOREXANT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2019-12-20	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-08-25	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-03-11	STANDARD
LABELING; Labeling	SUPPL	7	AP	2023-01-25	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	6

CDER Filings

EISAI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212028
            [companyName] => EISAI INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/212028s000lbl.pdf#page=21"]
            [products] => [{"drugName":"DAYVIGO","activeIngredients":"LEMBOREXANT","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"DAYVIGO","activeIngredients":"LEMBOREXANT","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/25\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212028s002lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212028s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/20\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212028s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212028Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/212028Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/25\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212028s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212028Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-08-25
        )

)