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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761324
Company: GENMAB US, INC.
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
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 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.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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