Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | EQ 4MG BASE | 1 | LENVIMA | LENVATINIB MESYLATE |
| 002 | CAPSULE;ORAL | EQ 10MG BASE | 1 | LENVIMA | LENVATINIB MESYLATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2015-02-13 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2016-05-13 | PRIORITY |
| LABELING; Labeling | SUPPL | 4 | AP | 2016-04-22 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2017-07-31 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2018-08-15 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2018-06-06 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2018-12-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2019-09-17 | PRIORITY |
| LABELING; Labeling | SUPPL | 12 | AP | 2020-02-20 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2020-04-23 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2020-11-10 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2020-09-14 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2020-12-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 19 | AP | 2021-08-10 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 20 | AP | 2021-07-21 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 21 | AP | 2021-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2022-11-10 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2022-08-05 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Orphan | 5 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 16 | Null | 6 |
| SUPPL | 17 | Null | 7 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 19 | Null | 30 |
| SUPPL | 20 | Null | 6 |
| SUPPL | 21 | Null | 15 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 6 |
CDER Filings
EISAI INC
cder:Array
(
[0] => Array
(
[ApplNo] => 206947
[companyName] => EISAI INC
[docInserts] => ["",""]
[products] => [{"drugName":"LENVIMA","activeIngredients":"LENVATINIB MESYLATE","strength":"EQ 4MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"LENVIMA","activeIngredients":"LENVATINIB MESYLATE","strength":"EQ 10MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
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[originalApprovals] => [{"actionDate":"02\/13\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206947s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206947Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206947Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206947Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"09\/14\/2020","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206947s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/206947Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"04\/23\/2020","submission":"SUPPL-13","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206947Orig1s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/206947Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"02\/20\/2020","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206947Orig1s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/206947Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"09\/17\/2019","submission":"SUPPL-11","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/206947s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/206947Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"12\/07\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206947s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206947Orig1s009Ltr.pdf\"}]","notes":">"},{"actionDate":"06\/06\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206947s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206947Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"08\/15\/2018","submission":"SUPPL-7","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206947s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206947Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"07\/31\/2017","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/206947s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/206947Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"04\/22\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206947s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206947Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"05\/13\/2016","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206947s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206947Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"10\/16\/2015","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-09-14
)
)