BLA 125156, held by Genentech. Ranibizumab.
As of Nov 13, 2026, BLA 125156 (Lucentis), held by Genentech, was first approved by FDA on Jun 30, 2006, with 17 approved supplements and 0 published complete response letters.
LUCENTIS is indicated for the treatment of patients with: LUCENTIS, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) Myopic Choroidal Neovascularization (mCNV) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) 1.2 Macular Edema Following Retinal Vein Occlusion (RVO) 1.3 Diabetic Macular Edema (DME) 1.4 Diabetic Retinopathy (DR) 1.5 Myopic Choroidal Neovascularization (mCNV)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 2017 | Supplement 114Efficacy (new indication or use) · Priority review | Approved | |
| Jan 5, 2017 | Supplement 111Efficacy (new indication or use) · Priority review | Approved | |
| Feb 6, 2015 | Supplement 106Efficacy (new indication or use) · Priority review | Approved | |
| Nov 25, 2014 | Supplement 105Efficacy (new indication or use) · Standard review | Approved | |
| Feb 27, 2014 | Supplement 94Efficacy (new indication or use) · Standard review | Approved | |
| Feb 6, 2013 | Supplement 81Efficacy (new indication or use) · Standard review | Approved | |
| Aug 10, 2012 | Supplement 76Efficacy (new indication or use) · Standard review | Approved | |
| Jun 22, 2010 | Supplement 53Efficacy (new indication or use) · Priority review | Approved | |
| Apr 23, 2008 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jun 30, 2006 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lucentis10MG/ML · injectable; injection | Ranibizumab | Rx |
| Lucentis6MG/ML · injectable; injection | Ranibizumab | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 15, 2024 | Supplement 128Labeling · Standard review | Approved | |
| Mar 20, 2018 | Supplement 117Manufacturing | Approved | |
| Apr 15, 2017 | Supplement 114Efficacy (new indication or use) · Priority review | Approved | |
| Jan 5, 2017 | Supplement 111Efficacy (new indication or use) · Priority review | Approved | |
| Nov 22, 2016 | Supplement 112Manufacturing · Standard review | Approved | |
| Oct 13, 2016 | Supplement 110 | Approved | |
| Feb 6, 2015 | Supplement 106Efficacy (new indication or use) · Priority review | Approved | |
| Nov 25, 2014 | Supplement 105Efficacy (new indication or use) · Standard review | Approved | |
| Feb 27, 2014 | Supplement 94Efficacy (new indication or use) · Standard review | Approved | |
| Mar 8, 2013 | Supplement 87Labeling · Standard review | Approved | |
| Feb 6, 2013 | Supplement 81Efficacy (new indication or use) · Standard review | Approved | |
| Aug 10, 2012 | Supplement 76Efficacy (new indication or use) · Standard review | Approved | |
| Aug 10, 2012 | Supplement 69Labeling · Standard review | Approved | |
| Jun 22, 2010 | Supplement 53Efficacy (new indication or use) · Priority review | Approved | |
| May 19, 2010 | Supplement 44Labeling · Standard review | Approved | None posted |
| Apr 23, 2008 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | None posted |
| Apr 26, 2007 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jun 30, 2006 | 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
