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Lucentis Approval History

FDA Approved: Yes (First approved June 30, 2006)
Brand name: Lucentis
Generic name: ranibizumab
Dosage form: Injection
Company: Genentech, Inc.
Treatment for: Macular Degeneration; Macular Edema; Diabetic Macular Edema; Diabetic Retinopathy; Myopic Choroidal Neovascularization

Lucentis (ranibizumab) is a humanized anti-VEGF antibody fragment indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.

Development History and FDA Approval Process for Lucentis

DateArticle
Mar 21, 2018Approval FDA Approves Genentech’s Lucentis (ranibizumab injection) 0.3 mg Prefilled Syringe for Diabetic Macular Edema and Diabetic Retinopathy
Apr 17, 2017Approval FDA Approves Genentech’s Lucentis (ranibizumab) for all Forms of Diabetic Retinopathy
Jan  5, 2017Approval FDA Approves Genentech’s Lucentis (ranibizumab) for Myopic Choroidal Neovascularization
Oct 14, 2016Approval FDA Approves Genentech’s Lucentis (ranibizumab) Prefilled Syringe
Feb  6, 2015Approval FDA Approves Lucentis (ranibizumab) to Treat Diabetic Retinopathy in People with Diabetic Macular Edema
Aug 10, 2012Approval FDA Approves Lucentis (ranibizumab) for Treatment of Diabetic Macular Edema (DME)
Jun 23, 2010Approval FDA Approves Lucentis (ranibizumab) for the Treatment of Macular Edema Following Retinal Vein Occlusion
Jun 30, 2006Approval FDA Approves Lucentis (ranibizumab) for the Treatment of Wet Age-Related Macular Degeneration
Dec 30, 2005Genentech Submits Biologics License Application for FDA Review of Lucentis in Wet Age-Related Macular Degeneration

Further information

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