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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761324
Company: GENMAB US, INC.

Medication Guide

Products on BLA 761324

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPKINLY	EPCORITAMAB-BYSP	4MG/0.8ML	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No
EPKINLY	EPCORITAMAB-BYSP	48MG/0.8ML	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761324

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/19/2023	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761324s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761324Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761324Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/17/2026	SUPPL-11	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761324Orig1s011ltr.pdf
03/27/2026	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761324s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761324Orig1s010ltr.pdf
11/18/2025	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761324s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761324Orig1s009ltr.pdf
09/11/2025	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761324s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761324Orig1s008ltr.pdf
06/26/2024	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761324s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761324Orig1s003ltr.pdf

Labels for BLA 761324

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/27/2026	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761324s010lbl.pdf
11/18/2025	SUPPL-9	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761324s009lbl.pdf
09/11/2025	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761324s008lbl.pdf
09/11/2025	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761324s008lbl.pdf
06/26/2024	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761324s003lbl.pdf
05/19/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761324s000lbl.pdf

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