An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 761379
Company: FRESENIUS KABI USA

Medication Guide

Products on BLA 761379

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OTULFI	USTEKINUMAB-AAUZ	45MG/0.5ML	INJECTABLE;INJECTION	Prescription	None	No	No
OTULFI	USTEKINUMAB-AAUZ	90MG/1ML	INJECTABLE;INJECTION	Prescription	None	No	No
OTULFI	USTEKINUMAB-AAUZ	130MG/26ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761379

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2025	ORIG-2	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379Orig2s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761379Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761379Orig2s000TOC.cfm
09/27/2024	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761379s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761379Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761379Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/14/2025	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761379Orig1s007ltr.pdf
08/14/2025	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761379Orig1s006ltr.pdf
04/30/2025	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761379Orig1s004ltr.pdf
02/19/2025	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761379Orig1s003ltr.pdf
03/21/2025	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761379Orig1s002ltr.pdf
04/14/2025	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761379Orig1s001ltr.pdf

Labels for BLA 761379

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/14/2025	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379Orig1s007lbl.pdf
08/14/2025	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379Orig1s006lbl.pdf
08/14/2025	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379Orig1s006lbl.pdf
04/30/2025	SUPPL-4	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379s004lbl.pdf
04/30/2025	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379Orig2s000lbl.pdf
04/14/2025	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379s001lbl.pdf
04/14/2025	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379s001lbl.pdf
04/14/2025	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379s001lbl.pdf
03/21/2025	SUPPL-2	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379Orig1s002lbl.pdf
02/19/2025	SUPPL-3		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761379s003lbl.pdf
09/27/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761379s001lbl.pdf

Top