← FDA DRUG APPROVALS

FDA BLA · BLA761202

BYOOVIZ

ranibizumab-nuna

Sponsor: SAMSUNG BIOEPIS CO LTD

APPLICATION
BLA761202
TYPE
BLA
ORIGINAL APPROVAL
2021-09-17
LATEST ACTION
2026-03-30
ROUTE
INTRAVITREAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BYOOVIZPrescription
RANIBIZUMAB-NUNA 0.5MG(10MG/ML) · INJECTABLE · INJECTION

Approval history

2026-03-30Labeling · Supplement 19 · standard — Label ↗AP
2025-11-12Labeling · Supplement 17 · standard — Label ↗AP
2025-08-15Labeling · Supplement 16 · standard — Label ↗AP
2023-10-03Efficacy · Supplement 6 · standard — Letter ↗AP
2023-06-16Labeling · Supplement 7 · standard — Label ↗AP
2022-08-15Labeling · Supplement 3 · standard — Letter ↗AP
2022-06-09Labeling · Supplement 4 · standard — Letter ↗AP
2021-09-17Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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