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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761139
Company: DAIICHI SANKYO

Medication Guide

Products on BLA 761139

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENHERTU	FAM-TRASTUZUMAB DERUXTECAN-NXKI	100MG	INJECTABLE;INJECTION	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761139

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2019	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761139s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761139Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761139Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2024	SUPPL-28	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761139s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761139Orig1s028ltr.pdf
02/15/2024	SUPPL-26	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761139s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761139Orig1s026ltr.pdf
11/04/2022	SUPPL-24	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761139s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761139Orig1s024ltr.pdf
08/05/2022	SUPPL-22	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761139s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761139Orig1s022ltr.pdf
08/11/2022	SUPPL-21	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761139s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761139Orig1s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761139Orig1s021.pdf
05/04/2022	SUPPL-20	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761139s017s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761139Orig1s017; s020ltr.pdf
05/04/2022	SUPPL-17	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761139s017s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761139Orig1s017; s020ltr.pdf
01/15/2021	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761139s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761139Orig1s011ltr.pdf

Labels for BLA 761139

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2024	SUPPL-28	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761139s028lbl.pdf
02/15/2024	SUPPL-26	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761139s026lbl.pdf
11/04/2022	SUPPL-24	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761139s024lbl.pdf
08/11/2022	SUPPL-21	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761139s021lbl.pdf
08/05/2022	SUPPL-22	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761139s022lbl.pdf
05/04/2022	SUPPL-20	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761139s017s020lbl.pdf
05/04/2022	SUPPL-17	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761139s017s020lbl.pdf
01/15/2021	SUPPL-11	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761139s011lbl.pdf
12/20/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761139s000lbl.pdf

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