BLA 761029, held by Biogen. Daclizumab.
As of Nov 13, 2026, BLA 761029 (Zinbryta), held by Biogen, was first approved by FDA on May 27, 2016, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 26, 2017 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| May 27, 2016 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zinbryta150MG/ML · injectable;injection | Daclizumab | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 1, 2017 | Supplement 5REMS | Approved | |
| Aug 28, 2017 | Supplement 2Labeling · Standard review | Approved | |
| Aug 28, 2017 | Supplement 7Labeling · Standard review | Approved | |
| May 26, 2017 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| May 27, 2016 | Original applicationNew molecular entity · 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
