← FDA DRUG APPROVALS

FDA BLA · BLA761430

IMAAVY

nipocalimab-aahu

Sponsor: JANSSEN BIOTECH

APPLICATION
BLA761430
TYPE
BLA
ORIGINAL APPROVAL
2025-04-29
LATEST ACTION
2025-04-29
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

IMAAVYPrescription
NIPOCALIMAB-AAHU 1200MG/6.5ML(185MG/ML) · INJECTABLE · INJECTION
IMAAVYPrescription
NIPOCALIMAB-AAHU 300MG/1.62ML(185MG/ML) · INJECTABLE · INJECTION

Approval history

2025-04-29Type 1 - New Molecular Entity · Original · priority — Label ↗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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