BLA 761359, held by Takeda Pharms USA. Vedolizumab.
As of Nov 14, 2026, BLA 761359 (Entyvio), held by Takeda Pharms USA, was first approved by FDA on Apr 18, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 18, 2024 | Original applicationEfficacy (new indication or use) · Standard review | Approved |
| Entyvio300MG · injectable;intravenous | Vedolizumab | Rx |
| Entyvio108MG/0.68ML · injectable;subcutaneous | Vedolizumab | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
