Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761097
Company: REGENERON PHARMACEUTICALS
Company: REGENERON PHARMACEUTICALS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIBTAYO | CEMIPLIMAB-RWLC | 350MG | INJECTABLE;INTRAVENOUS | Prescription | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 09/28/2018 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761097s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761097Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761097Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/06/2024 | SUPPL-25 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761097Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761097Orig1s025ltr.pdf | |
| 04/05/2024 | SUPPL-23 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761097s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761097Orig1s023ltr.pdf | |
| 04/28/2023 | SUPPL-16 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761097s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761097Orig1s016ltr.pdf | |
| 04/28/2023 | SUPPL-15 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761097s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761097Orig1s015ltr.pdf | |
| 11/08/2022 | SUPPL-14 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761097s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761097Orig1s014ltr.pdf | |
| 02/09/2021 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761097s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761097Orig1s009ltr.pdf | |
| 02/09/2021 | SUPPL-8 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761097s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761097Orig1s008ltr.pdf | |
| 02/22/2021 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761097s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761097Orig1s007ltr.pdf | |
| 06/25/2020 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761097s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761097Orig1s005ltr.pdf | |
| 11/10/2020 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761097s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761097Orig1s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761097Orig1s003.pdf | |
| 01/18/2019 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761097s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761097Orig1s002ltr.pdf | |
| 03/20/2019 | SUPPL-1 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761097s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761097Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/05/2024 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761097s023lbl.pdf | |
| 03/06/2024 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761097Orig1s025lbl.pdf | |
| 04/28/2023 | SUPPL-16 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761097s015s016lbl.pdf | |
| 04/28/2023 | SUPPL-15 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761097s015s016lbl.pdf | |
| 11/08/2022 | SUPPL-14 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761097s014lbl.pdf | |
| 02/22/2021 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761097s007lbl.pdf | |
| 02/09/2021 | SUPPL-9 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761097s009lbl.pdf | |
| 02/09/2021 | SUPPL-8 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761097s008lbl.pdf | |
| 11/10/2020 | SUPPL-3 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761097s003lbl.pdf | |
| 11/10/2020 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761097s003lbl.pdf | |
| 06/25/2020 | SUPPL-5 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761097s005lbl.pdf | |
| 03/20/2019 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761097s001lbl.pdf | |
| 01/18/2019 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761097s002lbl.pdf | |
| 09/28/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761097s000lbl.pdf |