Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 214665
Company: AMGEN INC
Company: AMGEN INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LUMAKRAS | SOTORASIB | 120MG | TABLET;ORAL | Prescription | None | Yes | No |
LUMAKRAS | SOTORASIB | 320MG | TABLET;ORAL | Prescription | None | Yes | Yes |
LUMAKRAS | SOTORASIB | 240MG | TABLET;ORAL | Prescription | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/28/2021 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214665s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214665Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214665Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/30/2024 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214665s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214665Orig1s012ltr.pdf | |
01/16/2025 | SUPPL-9 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214665s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214665Orig1s009ltr.pdf | |
03/17/2023 | SUPPL-7 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214665Orig1s007ltr.pdf |
04/24/2023 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214665s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214665Orig1s004ltr.pdf | |
01/20/2023 | SUPPL-3 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214665s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214665Orig1s003ltr.pdf | |
11/21/2022 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214665s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214665Orig1s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/16/2025 | SUPPL-9 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214665s009lbl.pdf | |
09/30/2024 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214665s012lbl.pdf | |
04/24/2023 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214665s004lbl.pdf | |
01/20/2023 | SUPPL-3 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214665s003lbl.pdf | |
01/20/2023 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214665s003lbl.pdf | |
11/21/2022 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214665s002lbl.pdf | |
05/28/2021 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214665s000lbl.pdf |