Drugs@FDA: FDA Approved Drug Products

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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
06/26/2019 SUPPL-14 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761055s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761055Orig1s014ltr.pdf
03/11/2019 SUPPL-12 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761055s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761055Orig1s012ltr.pdf
10/19/2018 SUPPL-7 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761055s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761055Orig1s007ltr.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
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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