FDA Approval for CABOMETYX issued to EXELIXIS INC
$EXEL
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
New Drug Application (NDA): 208692
Company: EXELIXIS INC
Company: EXELIXIS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CABOMETYX | CABOZANTINIB S-MALATE | EQ 20MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| CABOMETYX | CABOZANTINIB S-MALATE | EQ 40MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| CABOMETYX | CABOZANTINIB S-MALATE | EQ 60MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 04/25/2016 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208692s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208692Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208692Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/20/2023 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/14/2022 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208692s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208692Orig1s014ltr.pdf | |
| 02/13/2023 | SUPPL-13 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208692Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208692Orig1s013ltr.pdf | |
| 09/17/2021 | SUPPL-12 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208692s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208692Orig1s012correctedltr.pdf | |
| 01/22/2021 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208692s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208692Orig1s010ltr.pdf | |
| 11/05/2020 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208692Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208692Orig1s009ltr.pdf | |
| 07/16/2020 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208692s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208692Orig1s008ltr.pdf | |
| 01/31/2020 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208692s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208692Orig1s007ltr.pdf | |
| 01/14/2019 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208692s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208692Orig1s003ltr.pdf | |
| 12/19/2017 | SUPPL-2 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208692s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208692Orig1s002ltr.pdf | |
| 11/16/2017 | SUPPL-1 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208692Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/13/2023 | SUPPL-13 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208692Orig1s013lbl.pdf | |
| 02/13/2023 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208692Orig1s013lbl.pdf | |
| 07/14/2022 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208692s014lbl.pdf | |
| 09/17/2021 | SUPPL-12 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208692s012lbl.pdf | |
| 01/22/2021 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208692s010lbl.pdf | |
| 11/05/2020 | SUPPL-9 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208692Orig1s009lbl.pdf | |
| 07/16/2020 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208692s008lbl.pdf | |
| 01/31/2020 | SUPPL-7 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208692s007lbl.pdf | |
| 01/31/2020 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208692s007lbl.pdf | |
| 01/14/2019 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208692s003lbl.pdf | |
| 12/19/2017 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208692s002lbl.pdf | |
| 04/25/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208692s000lbl.pdf |