Treats moderately to severely active rheumatoid arthritis. BLA 761449, held by Fresenius Kabi USA. Tocilizumab-Aazg.
As of Nov 13, 2026, BLA 761449 (Tyenne), held by Fresenius Kabi USA, was first approved by FDA on Mar 14, 2025, with 2 approved supplements and 0 published complete response letters.
TYENNE (tocilizumab-aazg) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: Rheumatoid Arthritis (RA)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 14, 2025 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tyenne162MG/0.9ML · injectable;subcutaneous | Tocilizumab-Aazg | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 20, 2026 | Supplement 6Labeling · Standard review | Approved | |
| May 12, 2025 | Supplement 1Labeling · Standard review | Approved | |
| Mar 14, 2025 | Original application | Approved |
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
