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FDA BLA · BLA761125

BEOVU

brolucizumab

Sponsor: NOVARTIS PHARMS CORP

APPLICATION
BLA761125
TYPE
BLA
ORIGINAL APPROVAL
2019-10-07
LATEST ACTION
2024-07-29
ROUTE
INTRAVITREAL
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BEOVUPrescription
brolucizumab-dbll 6MG/0.05ML · INJECTABLE · INTRAVITREAL

Approval history

2024-07-29Labeling · Supplement 21 · standard — Letter ↗AP
2023-09-28Labeling · Supplement 20 · standard — Label ↗AP
2022-12-19Labeling · Supplement 17 · standard — Label ↗AP
2022-05-27Efficacy · Supplement 8 · standard — Letter ↗AP
2022-03-09Manufacturing (CMC) · Supplement 2AP
2022-02-18Labeling · Supplement 12 · standard — Label ↗AP
2022-02-18Labeling · Supplement 10 · standard — Label ↗AP
2022-02-18Labeling · Supplement 13 · standard — Label ↗AP
2020-06-09Labeling · Supplement 4 · standard — Letter ↗AP
2019-10-07Type 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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