← FDA DRUG APPROVALS

FDA BLA · BLA125387

EYLEA

aflibercept

Sponsor: REGENERON PHARMACEUTICALS

APPLICATION
BLA125387
TYPE
BLA
ORIGINAL APPROVAL
2011-11-18
LATEST ACTION
2024-10-10
ROUTE
INTRAVITREAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

EYLEAPrescription
AFLIBERCEPT 40MG/ML · INJECTABLE · INJECTION

Approval history

2024-10-10Labeling · Supplement 87 · standard — Label ↗AP
2023-12-14Labeling · Supplement 84 · standard — Label ↗AP
2023-02-08Efficacy · Supplement 75 · priority — Letter ↗AP
2022-09-06Labeling · Supplement 76 · standard — Letter ↗AP
2021-03-30Labeling · Supplement 69 · standard — Letter ↗AP
2019-08-12Labeling · Supplement 60 · standard — Label ↗AP
2019-05-13Efficacy · Supplement 61 · standard — Label ↗AP
2018-08-16Labeling · Supplement 58 · standard — Label ↗AP
2018-08-16Efficacy · Supplement 56 · standard — Label ↗AP
2017-05-26Labeling · Supplement 54 · standard — Label ↗AP
2016-10-28Manufacturing (CMC) · Supplement 53 · standard — Review ↗AP
2016-10-24Labeling · Supplement 52 · standard — Letter ↗AP
2016-05-24Labeling · Supplement 51 · standard — Label ↗AP
2015-07-30Labeling · Supplement 36 · standard — Label ↗AP
2015-03-25Efficacy · Supplement 48 · priority — Review ↗AP
2014-10-06Efficacy · Supplement 43 · standard — Label ↗AP
2014-07-29Efficacy · Supplement 37 · standard — Letter ↗AP
2014-01-27Labeling · Supplement 23 · standard — Review ↗AP
2013-06-07Labeling · Supplement 15 · standard — Label ↗AP
2013-06-07Labeling · Supplement 20 · standard — Label ↗AP
2012-09-21Efficacy · Supplement 4 · standard — Label ↗AP
2011-11-18Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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