Biologic License Application (BLA): 761331
Company: AMGEN INC

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
WEZLANA	USTEKINUMAB-AUUB	130MG/26ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	None	No	No

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

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/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	Url
09/25/2025	SUPPL-4	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761285s004,761331s004lbl.pdf
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
12/26/2024	SUPPL-1	Labeling-Package Insert	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