BLA 761197, held by Genentech Inc. Ranibizumab.
As of Nov 13, 2026, BLA 761197 (Susvimo), held by Genentech Inc, was first approved by FDA on Oct 22, 2021, with 4 approved supplements and 0 published complete response letters.
SUSVIMO (ranibizumab injection) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a VEGF inhibitor. Diabetic Macular Edema (DME) who have previously responded to at least two intravitreal injections of a VEGF inhibitor. Diabetic Retinopathy (DR) who have previously responded to at least two intravitreal injections of a VEGF inhibitor. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 21, 2025 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Feb 3, 2025 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Oct 22, 2021 | Original applicationNew active ingredient · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Susvimo100MG/ML · solution;injection | Ranibizumab | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 5, 2025 | Supplement 8Labeling · Standard review | Approved | |
| May 21, 2025 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Feb 3, 2025 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Apr 18, 2022 | Supplement 2Labeling · Standard review | Approved | |
| Oct 22, 2021 | Original applicationNew active ingredient · 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
