Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204114
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEKINIST | TRAMETINIB DIMETHYL SULFOXIDE | EQ 0.5MG | TABLET;ORAL | Prescription | None | Yes | No |
| MEKINIST | TRAMETINIB DIMETHYL SULFOXIDE | EQ 1MG | TABLET;ORAL | Discontinued | None | Yes | No |
| MEKINIST | TRAMETINIB DIMETHYL SULFOXIDE | EQ 2MG | 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 | Url |
|---|---|---|---|---|---|---|---|
| 05/29/2013 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204114s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204114Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204114Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204114Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/29/2024 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204114s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204114Orig1s032ltr.pdf | |
| 02/27/2024 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204114s031,217513s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204114Orig1s031; 217513Orig1s002ltr.pdf | |
| 08/31/2023 | SUPPL-29 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204114s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204114Orig1s029ltr.pdf | |
| 05/26/2023 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204114s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204114Orig1s028ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204114Orig1s028ltr.pdf | |
| 03/16/2023 | SUPPL-25 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204114s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204114Orig1s025ltr.pdf | |
| 06/22/2022 | SUPPL-24 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204114s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204114Orig1s024ltr.pdf | |
| 05/27/2022 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204114s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204114Orig1s023ltr.pdf | |
| 01/28/2022 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204114s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204114Orig1s021ltr.pdf | |
| 12/03/2021 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204114s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204114Orig1s020ltr.pdf | |
| 01/28/2022 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204114s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204114Orig1s019ltr.pdf | |
| 05/07/2021 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204114s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204114Orig1s018ltr.pdf | |
| 06/23/2020 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204114s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204114Orig1s016ltr.pdf | |
| 04/09/2020 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204114s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204114Orig1s014ltr.pdf | |
| 07/16/2019 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204114s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204114Orig1s013ltr.pdf | |
| 10/06/2019 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204114s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204114Orig1s012ltr.pdf | |
| 05/04/2018 | SUPPL-9 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204114Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204114Orig1s009ltr.pdf | |
| 03/09/2018 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204114s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204114Orig1s008ltr.pdf | |
| 04/30/2018 | SUPPL-7 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204114s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204114Orig1s007ltr.pdf | |
| 02/24/2017 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204114s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204114Orig1s006ltr.pdf | |
| 06/22/2017 | SUPPL-5 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204114s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204114Orig1s005ltr.pdf | |
| 11/20/2015 | SUPPL-4 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204114s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204114Orig1s004ltr.pdf | |
| 09/26/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/2014 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/08/2014 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204114s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204114Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/29/2024 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204114s032lbl.pdf | |
| 02/27/2024 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204114s031,217513s002lbl.pdf | |
| 08/31/2023 | SUPPL-29 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204114s029lbl.pdf | |
| 05/26/2023 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204114s028lbl.pdf | |
| 03/16/2023 | SUPPL-25 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204114s025lbl.pdf | |
| 06/22/2022 | SUPPL-24 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204114s024lbl.pdf | |
| 05/27/2022 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204114s023lbl.pdf | |
| 01/28/2022 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204114s021lbl.pdf | |
| 01/28/2022 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204114s019lbl.pdf | |
| 12/03/2021 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204114s020lbl.pdf | |
| 05/07/2021 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204114s018lbl.pdf | |
| 06/23/2020 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204114s016lbl.pdf | |
| 04/09/2020 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204114s014lbl.pdf | |
| 10/06/2019 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204114s012lbl.pdf | |
| 07/16/2019 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204114s013lbl.pdf | |
| 05/04/2018 | SUPPL-9 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204114Orig1s009lbl.pdf | |
| 04/30/2018 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204114s007lbl.pdf | |
| 03/09/2018 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204114s008lbl.pdf | |
| 03/09/2018 | SUPPL-8 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204114s008lbl.pdf | |
| 06/22/2017 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204114s005lbl.pdf | |
| 02/24/2017 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204114s006lbl.pdf | |
| 11/20/2015 | SUPPL-4 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204114s004lbl.pdf | |
| 01/08/2014 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204114s001lbl.pdf | |
| 05/29/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204114s000lbl.pdf |