← FDA DRUG APPROVALS

FDA BLA · BLA761433

RYBREVANT FASPRO

amivantamab and hyaluronidase-lpuj (human recombinant)

Sponsor: JANSSEN BIOTECH

APPLICATION
BLA761433
TYPE
BLA
ORIGINAL APPROVAL
2025-12-17
LATEST ACTION
2025-12-17
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTION
MARKETING STATUS
Prescription

Products

RYBREVANT FASPROPrescription
AMIVANTAMAB AND HYALURONIDASE-LPUJ 14ML · INJECTION
RYBREVANT FASPROPrescription
AMIVANTAMAB AND HYALURONIDASE-LPUJ 10ML · INJECTION

Approval history

2025-12-17Type 5 - New Formulation or New Manufacturer · 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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