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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761449
Company: FRESENIUS KABI USA

Medication Guide

Products on BLA 761449

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TYENNE	TOCILIZUMAB-AAZG	162MG/0.9ML	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761449

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/14/2025	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761449s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761449Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/761449Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/20/2026	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761449s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761449Orig1s006ltr.pdf
05/12/2025	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761275s004,761449s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761275Orig1s004, 761449Orig1s001ltr.pdf

Labels for BLA 761449

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/20/2026	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761449s006lbl.pdf
05/20/2026	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761449s006lbl.pdf
05/12/2025	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761275s004,761449s001lbl.pdf
05/12/2025	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761275s004,761449s001lbl.pdf
05/12/2025	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761275s004,761449s001lbl.pdf
03/14/2025	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761449s000lbl.pdf

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