Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 206947
Company: EISAI INC
Company: EISAI INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LENVIMA | LENVATINIB MESYLATE | EQ 4MG BASE | CAPSULE;ORAL | Prescription | None | Yes | No |
| LENVIMA | LENVATINIB MESYLATE | EQ 10MG BASE | CAPSULE;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 | Url |
|---|---|---|---|---|---|---|---|
| 02/13/2015 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206947s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206947Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206947Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206947Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/03/2024 | SUPPL-30 | Efficacy-Manufacturing Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206947s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/206947Orig1s030ltr.pdf | |
| 10/23/2023 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206947s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206947Orig1s028ltr.pdf | |
| 08/05/2022 | SUPPL-25 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206947s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206947Orig1s025ltr.pdf | |
| 11/10/2022 | SUPPL-24 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206947s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206947Orig1s024ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/206947Orig1s024.pdf | |
| 12/19/2021 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206947s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206947Orig1s021ltr.pdf | |
| 07/21/2021 | SUPPL-20 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206947s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206947Orig1s020ltr.pdf | |
| 08/10/2021 | SUPPL-19 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206947Orig1s019ltr.pdf | |
| 12/18/2020 | SUPPL-18 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206947Orig1s018ltr.pdf | |
| 09/14/2020 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206947Orig1s017ltr.pdf | |
| 11/10/2020 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206947Orig1s016ltr.pdf | |
| 04/23/2020 | SUPPL-13 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206947Orig1s013ltr.pdf | |
| 02/20/2020 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206947Orig1s012ltr.pdf | |
| 09/17/2019 | SUPPL-11 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206947s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206947Orig1s011ltr.pdf | |
| 12/07/2018 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206947s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206947Orig1s009Ltr.pdf | |
| 06/06/2018 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206947s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206947Orig1s008ltr.pdf | |
| 08/15/2018 | SUPPL-7 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206947s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206947Orig1s007ltr.pdf | |
| 07/31/2017 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206947s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206947Orig1s005ltr.pdf | |
| 04/22/2016 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206947s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206947Orig1s004ltr.pdf | |
| 05/13/2016 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206947s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206947Orig1s003ltr.pdf | |
| 10/16/2015 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/03/2024 | SUPPL-30 | Efficacy-Manufacturing Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/206947s030lbl.pdf | |
| 10/23/2023 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206947s028lbl.pdf | |
| 11/10/2022 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206947s024lbl.pdf | |
| 11/10/2022 | SUPPL-24 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206947s024lbl.pdf | |
| 08/05/2022 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206947s025lbl.pdf | |
| 08/05/2022 | SUPPL-25 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206947s025lbl.pdf | |
| 12/19/2021 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206947s021lbl.pdf | |
| 08/10/2021 | SUPPL-19 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947s019lbl.pdf | |
| 07/21/2021 | SUPPL-20 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206947s020lbl.pdf | |
| 12/18/2020 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947s018lbl.pdf | |
| 12/18/2020 | SUPPL-18 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947s018lbl.pdf | |
| 11/10/2020 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947s016lbl.pdf | |
| 09/14/2020 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947s017lbl.pdf | |
| 04/23/2020 | SUPPL-13 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947Orig1s013lbl.pdf | |
| 02/20/2020 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206947Orig1s012lbl.pdf | |
| 09/17/2019 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206947s011lbl.pdf | |
| 12/07/2018 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206947s009lbl.pdf | |
| 08/15/2018 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206947s007lbl.pdf | |
| 06/06/2018 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206947s008lbl.pdf | |
| 07/31/2017 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206947s005lbl.pdf | |
| 05/13/2016 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206947s003lbl.pdf | |
| 04/22/2016 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206947s004lbl.pdf | |
| 02/13/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206947s000lbl.pdf |