Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761324
Company: GENMAB US, INC.
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 |