Tyenne

Treats moderately to severely active rheumatoid arthritis. BLA 761275, held by Fresenius Kabi USA. Tocilizumab-Aazg.

As of Nov 13, 2026, BLA 761275 (Tyenne), held by Fresenius Kabi USA, was first approved by FDA on Mar 5, 2024, with 8 approved supplements and 1 published complete response letter.

First approved: Mar 5, 2024
Review: Standard
Supplements approved: 8
Complete response letters: 1

What It's For

From the FDA-approved label (Indications and Usage)

TYENNE (tocilizumab-aazg) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA)

Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA)
Adult patients with giant cell arteritis. Polyarticular Juvenile Idiopathic Arthritis (PJIA)
Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. Systemic Juvenile Idiopathic Arthritis (SJIA)
Patients 2 years of age and older with active systemic juvenile idiopathic arthritis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Mar 5, 2024	Original application	Approved	Review Letter Label

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
May 31, 2023	MSB11456Facilities	Approved

Products

3 strengths and forms

Product	Active ingredient	Marketing
Tyenne80MG/4ML · injectable;intravenous	Tocilizumab-Aazg	Rx
Tyenne200MG/10ML · injectable;intravenous	Tocilizumab-Aazg	Rx
Tyenne400MG/20ML · injectable;intravenous	Tocilizumab-Aazg	Rx

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 21, 2026	Supplement 22Labeling · Standard review	Approved	Medication Guide Label Letter
Jan 21, 2026	Supplement 19Labeling · Standard review	Approved	Letter Label
May 12, 2025	Supplement 4Labeling · Standard review	Approved	Letter Label Medication Guide
Mar 13, 2025	Supplement 15Labeling · Standard review	Approved	Label
Feb 28, 2025	Supplement 8Biosimilar · Standard review	Approved	Letter Label
Dec 13, 2024	Supplement 13Labeling · Standard review	Approved	Label Letter
Dec 3, 2024	Supplement 11Labeling · Standard review	Approved	Label Letter
Sep 5, 2024	Supplement 1Manufacturing	Approved	Label
Mar 5, 2024	Original application	Approved	Review Letter Label

Identifiers

Application: BLA 761275
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters