U.S. License Holder:
Genentech
Date of License:
June-30-2006
Last Update:
January-08-2021
FDA-Approved Indications
LUCENTIS (ranibizumab), 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 in patients with DME.
aBLA / 505(b)(2) Activity
aBLA / 505(b)(2) Accepted by FDA
FYB201: Formycon / Bioeq (December-2019, withdrawn February-2020 with plan to resubmit) SB11 (Samsung Bioepis / Biogen) (November-2020)