Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202806
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TAFINLAR | DABRAFENIB MESYLATE | EQ 50MG BASE | CAPSULE;ORAL | Prescription | None | Yes | No |
| TAFINLAR | DABRAFENIB MESYLATE | EQ 75MG 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 |
|---|---|---|---|---|---|---|---|
| 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/2013/202806s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202806Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202806Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/31/2023 | SUPPL-27 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202806s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202806Orig1s027ltr.pdf | |
| 05/26/2023 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202806s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202806Orig1s026ltr.pdf | |
| 03/16/2023 | SUPPL-25 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202806s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202806Orig1s025ltr.pdf | |
| 05/27/2022 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202806s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202806Orig1s023ltr.pdf | |
| 06/22/2022 | SUPPL-22 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202806s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202806Orig1s022ltr.pdf | |
| 02/04/2022 | SUPPL-21 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202806Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202806Orig1s021ltr.pdf | |
| 12/03/2021 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202806s020lbl.pdf | |
| 01/28/2022 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202806s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202806Orig1s019ltr.pdf | |
| 05/07/2021 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202806s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202806Orig1s017ltr.pdf | |
| 04/09/2020 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202806s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202806Orig1s015ltr.pdf | |
| 07/16/2019 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202806s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202806Orig1s013ltr.pdf | |
| 10/06/2019 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202806s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202806Orig1s012ltr.pdf | |
| 05/04/2018 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202806s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202806Orig1s010ltr.pdf | |
| 04/20/2018 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202806s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202806Orig1s009ltr.pdf | |
| 04/30/2018 | SUPPL-8 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202806s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202806Orig1s008ltr.pdf | |
| 06/16/2017 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202806s007lbl.pdf | |
| 06/22/2017 | SUPPL-6 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202806s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202806Orig1s006ltr.pdf | |
| 06/16/2016 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202806s005lbl.pdf | |
| 11/20/2015 | SUPPL-4 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202806s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202806Orig1s004ltr.pdf | |
| 08/25/2014 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/2014 | SUPPL-2 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202806s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202806Orig1s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/202806Orig1s002.pdf | |
| 12/26/2013 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202806Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/31/2023 | SUPPL-27 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202806s027lbl.pdf | |
| 05/26/2023 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202806s026lbl.pdf | |
| 03/16/2023 | SUPPL-25 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202806s025lbl.pdf | |
| 06/22/2022 | SUPPL-22 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202806s022lbl.pdf | |
| 05/27/2022 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202806s023lbl.pdf | |
| 02/04/2022 | SUPPL-21 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202806Orig1s021lbl.pdf |
| 01/28/2022 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202806s019lbl.pdf | |
| 12/03/2021 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202806s020lbl.pdf | |
| 05/07/2021 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202806s017lbl.pdf | |
| 04/09/2020 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202806s015lbl.pdf | |
| 10/06/2019 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202806s012lbl.pdf | |
| 07/16/2019 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202806s013lbl.pdf | |
| 05/04/2018 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202806s010lbl.pdf | |
| 04/30/2018 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202806s008lbl.pdf | |
| 04/20/2018 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202806s009lbl.pdf | |
| 06/22/2017 | SUPPL-6 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202806s006lbl.pdf | |
| 06/16/2017 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202806s007lbl.pdf | |
| 06/16/2016 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202806s005lbl.pdf | |
| 11/20/2015 | SUPPL-4 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202806s004lbl.pdf | |
| 01/09/2014 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202806s002lbl.pdf | |
| 12/26/2013 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806s001lbl.pdf | |
| 05/29/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806s000lbl.pdf |