Treats relapsing forms of multiple sclerosis. BLA 761322, held by Sandoz Inc. Natalizumab-Sztn.
As of Nov 13, 2026, BLA 761322 (Tyruko), held by Sandoz Inc, was first approved by FDA on Aug 24, 2023, with 3 approved supplements and 0 published complete response letters.
TYRUKO is an integrin receptor antagonist indicated for treatment of: Multiple Sclerosis (MS) TYRUKO is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Natalizumab products increase the risk of PML. When initiating and continuing treatment with TYRUKO, physicians should consider whether the expected benefit of TYRUKO is sufficient to offset this risk.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 24, 2023 | Original applicationNew active ingredient · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tyruko300MG/15ML(20MG/ML) · injectable;injection | Natalizumab-Sztn | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 23, 2026 | Supplement 8REMS | Approved | |
| Feb 2, 2026 | Supplement 7REMS | Approved | None posted |
| Oct 30, 2025 | Supplement 2Labeling · Standard review | Approved | |
| Aug 24, 2023 | Original applicationNew active ingredient · Standard review | 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
