Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761285
Company: AMGEN INC

• Medication Guide

Products on BLA 761285

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
WEZLANA	USTEKINUMAB-AUUB	130MG/26ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761285

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.cfm

Labels for BLA 761285

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761285s000,761331s000lbl.pdf