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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761097
Company: REGENERON PHARMACEUTICALS

Medication Guide

Products on BLA 761097

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIBTAYO	CEMIPLIMAB-RWLC	350MG	INJECTABLE;INTRAVENOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761097

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/29/2025	SUPPL-32	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761097s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761097Orig1s032ltr.pdf
10/08/2025	SUPPL-30	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761097s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761097Orig1s030ltr.pdf
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

Labels for BLA 761097

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/29/2025	SUPPL-32	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761097s032lbl.pdf
10/08/2025	SUPPL-30	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761097s030lbl.pdf
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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