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Biologic License Application (BLA): 761055
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
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
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-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
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
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