← FDA DRUG APPROVALS

FDA BLA · BLA125156

LUCENTIS

ranibizumab

Sponsor: GENENTECH

APPLICATION
BLA125156
TYPE
BLA
ORIGINAL APPROVAL
2006-06-30
LATEST ACTION
2024-02-15
ROUTE
INTRAVITREAL, Injection, INJECTION
DOSAGE FORM
Injectable, INJECTABLE
MARKETING STATUS
Prescription

Products

LUCENTISPrescription
RANIBIZUMAB 6MG/ML · Injectable · Injection
LUCENTISPrescription
RANIBIZUMAB 10MG/ML · INJECTABLE · INJECTION

Approval history

2024-02-15Labeling · Supplement 128 · standard — Letter ↗AP
2018-03-20Manufacturing (CMC) · Supplement 117 — Letter ↗AP
2017-04-15Efficacy · Supplement 114 · priority — Label ↗AP
2017-01-05Efficacy · Supplement 111 · priority — Label ↗AP
2016-11-22Manufacturing (CMC) · Supplement 112 · standard — Letter ↗AP
2016-10-13Supplement · Supplement 110 · unknown — Label ↗AP
2015-02-06Efficacy · Supplement 106 · priority — Review ↗AP
2014-11-25Efficacy · Supplement 105 · standard — Letter ↗AP
2014-02-27Efficacy · Supplement 94 · standard — Label ↗AP
2013-03-08Labeling · Supplement 87 · standard — Letter ↗AP
2013-02-06Efficacy · Supplement 81 · standard — Label ↗AP
2012-08-10Efficacy · Supplement 76 · standard — Label ↗AP
2012-08-10Labeling · Supplement 69 · standard — Label ↗AP
2010-06-22Efficacy · Supplement 53 · priority — Review ↗AP
2010-05-19Labeling · Supplement 44 · standardAP
2008-04-23Efficacy · Supplement 11 · standardAP
2007-04-26Labeling · Supplement 3 · standardAP
2006-06-30Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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