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Biologic License Application (BLA): 761097
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761097s003lbl.pdf
11/10/2020 SUPPL-3 Labeling-Medication Guide 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
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