FDA Approval for WEZLANA issued to AMGEN INC
$AMGN
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
Biologic License Application (BLA): 761285
Company: AMGEN INC
Company: AMGEN INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| WEZLANA | USTEKINUMAB-AUUB | 45MG/0.5ML | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Prescription | None | No | No |
| WEZLANA | USTEKINUMAB-AUUB | 90MG/ML | INJECTABLE;INTRAVENOUS, 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 |
|---|---|---|---|---|---|---|---|
| 10/31/2023 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761285s000,761331s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761285Orig1s000; 761331Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761285Orig1s000,761331Orig1s000TOC.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/12/2026 | SUPPL-6 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761285Orig1s006, 761331Orig1s006ltr.pdf |
| 09/25/2025 | SUPPL-4 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761285s004,761331s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761285Orig1s004,761331Orig1s004ltr.pdf | |
| 12/26/2024 | SUPPL-1 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761285s001,761331s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761285Orig1s001;761331Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/25/2025 | SUPPL-4 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761285s004,761331s004lbl.pdf | |
| 09/25/2025 | SUPPL-4 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761285s004,761331s004lbl.pdf | |
| 09/25/2025 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761285s004,761331s004lbl.pdf | |
| 12/26/2024 | SUPPL-1 | Efficacy-Manufacturing Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761285s001,761331s001lbl.pdf | |
| 10/31/2023 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761285s000,761331s000lbl.pdf |