BLA 761125, held by Novartis Pharms Corp. brolucizumab-dbll.
As of Nov 13, 2026, BLA 761125 (Beovu), held by Novartis Pharms Corp, was first approved by FDA on Oct 7, 2019, with 9 approved supplements and 0 published complete response letters.
BEOVU is indicated for the treatment of: BEOVU is a human vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Diabetic Macular Edema (DME) 1.1 Neovascular (Wet) Age-related Macular Degeneration (AMD) 1.2 Diabetic Macular Edema (DME)
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 27, 2022 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Oct 7, 2019 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Beovu6MG/0.05ML · injectable; intravitreal | brolucizumab-dbll | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 29, 2024 | Supplement 21Labeling · Standard review | Approved | |
| Sep 28, 2023 | Supplement 20Labeling · Standard review | Approved | |
| Dec 19, 2022 | Supplement 17Labeling · Standard review | Approved | |
| May 27, 2022 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Mar 9, 2022 | Supplement 2Manufacturing | Approved | None posted |
| Feb 18, 2022 | Supplement 10Labeling · Standard review | Approved | |
| Feb 18, 2022 | Supplement 12Labeling · Standard review | Approved | |
| Feb 18, 2022 | Supplement 13Labeling · Standard review | Approved | |
| Jun 9, 2020 | Supplement 4Labeling · Standard review | Approved | |
| Oct 7, 2019 | Original applicationNew molecular entity · Priority 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
