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FDA BLA · BLA761197

SUSVIMO

ranibizumab

Sponsor: GENENTECH INC

APPLICATION
BLA761197
TYPE
BLA
ORIGINAL APPROVAL
2021-10-22
LATEST ACTION
2025-09-05
ROUTE
INTRAVITREAL, INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

SUSVIMOPrescription
RANIBIZUMAB 100MG/ML · SOLUTION · INJECTION

Approval history

2025-09-05Labeling · Supplement 8 · standard — Letter ↗AP
2025-05-21Efficacy · Supplement 7 · standard — Letter ↗AP
2025-02-03Efficacy · Supplement 6 · standard — Label ↗AP
2022-04-18Labeling · Supplement 2 · standard — Letter ↗AP
2021-10-22Type 2 - New Active Ingredient · 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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