Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761055
Company: REGENERON PHARMACEUTICALS
Company: REGENERON PHARMACEUTICALS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DUPIXENT | DUPILUMAB | 150MG/ML | INJECTABLE; INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/28/2017 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761055Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761055Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/12/2024 | SUPPL-59 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761055s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761055Orig1s059ltr.pdf | |
| 01/25/2024 | SUPPL-57 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761055s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761055Orig1s057ltr.pdf | |
| 01/12/2024 | SUPPL-55 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761055s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761055Orig1s055ltr.pdf | |
| 09/29/2023 | SUPPL-54 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761055s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761055Orig1s054ltr.pdf | |
| 07/14/2023 | SUPPL-50 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761055s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761055Orig1s050ltr.pdf | |
| 10/17/2022 | SUPPL-46 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761055s046lbl.pdf | |
| 09/28/2022 | SUPPL-44 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761055s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761055Orig1s044ltr.pdf | |
| 06/07/2022 | SUPPL-42 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761055s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761055Orig1s042ltr.pdf | |
| 05/20/2022 | SUPPL-40 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761055s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761055Orig1s040ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761055Orig1s040.pdf | |
| 10/01/2021 | SUPPL-35 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761055s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761055Orig1s035ltr.pdf | |
| 12/22/2021 | SUPPL-33 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761055s021s027s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761055Orig1s021, s027, s033ltr.pdf | |
| 10/20/2021 | SUPPL-31 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761055s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761055Orig1s031ltr.pdf | |
| 12/22/2021 | SUPPL-27 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761055s021s027s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761055Orig1s021, s027, s033ltr.pdf | |
| 12/22/2021 | SUPPL-21 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761055s021s027s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761055Orig1s021, s027, s033ltr.pdf | |
| 05/26/2020 | SUPPL-20 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761055s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761055Orig1s020ltr.pdf | |
| 06/18/2020 | SUPPL-17 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761055s015s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761055Orig1s015,s017ltr.pdf | |
| 06/14/2021 | SUPPL-16 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761055s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761055Orig1s016ltr.pdf | |
| 06/18/2020 | SUPPL-15 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761055s015s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761055Orig1s015,s017ltr.pdf | |
| 06/26/2019 | SUPPL-14 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761055s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761055Orig1s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761055Orig1s014rev.pdf | |
| 03/11/2019 | SUPPL-12 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761055s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761055Orig1s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761055Orig1s012.pdf | |
| 10/19/2018 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761055s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761055Orig1s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761055Orig1s007.pdf | |
| 01/10/2018 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761055s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761055Orig1s005ltr.pdf | |
| 04/10/2018 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761055s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761055Orig1s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/12/2024 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761055s059lbl.pdf | |
| 01/25/2024 | SUPPL-57 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761055s057lbl.pdf | |
| 01/12/2024 | SUPPL-55 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761055s055lbl.pdf | |
| 09/29/2023 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761055s054lbl.pdf | |
| 07/14/2023 | SUPPL-50 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761055s050lbl.pdf | |
| 10/17/2022 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761055s046lbl.pdf | |
| 10/17/2022 | SUPPL-46 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761055s046lbl.pdf | |
| 09/28/2022 | SUPPL-44 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761055s044lbl.pdf | |
| 06/07/2022 | SUPPL-42 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761055s042lbl.pdf | |
| 05/20/2022 | SUPPL-40 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761055s040lbl.pdf | |
| 12/22/2021 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761055s021s027s033lbl.pdf | |
| 12/22/2021 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761055s021s027s033lbl.pdf | |
| 12/22/2021 | SUPPL-27 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761055s021s027s033lbl.pdf | |
| 12/22/2021 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761055s021s027s033lbl.pdf | |
| 12/22/2021 | SUPPL-21 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761055s021s027s033lbl.pdf | |
| 10/20/2021 | SUPPL-31 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761055s031lbl.pdf | |
| 10/01/2021 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761055s035lbl.pdf | |
| 06/14/2021 | SUPPL-16 | Efficacy-Manufacturing Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761055s016lbl.pdf | |
| 06/18/2020 | SUPPL-17 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761055s015s017lbl.pdf | |
| 06/18/2020 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761055s015s017lbl.pdf | |
| 06/18/2020 | SUPPL-15 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761055s015s017lbl.pdf | |
| 05/26/2020 | SUPPL-20 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761055s020lbl.pdf | |
| 06/26/2019 | SUPPL-14 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761055s014lbl.pdf | |
| 03/11/2019 | SUPPL-12 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761055s012lbl.pdf | |
| 10/19/2018 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761055s007lbl.pdf | |
| 04/10/2018 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761055s003lbl.pdf | |
| 01/10/2018 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761055s005lbl.pdf | |
| 03/28/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761055lbl.pdf |