BLA 125399, held by Seattle Genetics. Brentuximab Vedotin.
As of Nov 13, 2026, BLA 125399 (Adcetris), held by Seattle Genetics, was first approved by FDA on Aug 19, 2011, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 19, 2011 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Adcetris50MG/VIAL ยท injectable; injection | Brentuximab Vedotin | Rx |
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
