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FDA BLA · BLA761235

VABYSMO

faricimab

Sponsor: GENENTECH INC

APPLICATION
BLA761235
TYPE
BLA
ORIGINAL APPROVAL
2022-01-28
LATEST ACTION
2026-04-09
ROUTE
INTRAVITREAL
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

VABYSMOPrescription
FARICIMAB-SVOA 120MG/ML · INJECTABLE · INTRAVITREAL

Approval history

2026-04-09Efficacy · Supplement 8 · standard — Letter ↗AP
2024-07-03Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2023-10-26Efficacy · Supplement 3 · standard — Letter ↗AP
2023-01-27Efficacy · Supplement 1 · standard — Label ↗AP
2022-01-28Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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