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Rybrevant Faspro

amivantamab and hyaluronidase-lpuj

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Rybrevant Faspro
Proper name
amivantamab and hyaluronidase-lpuj
Licence type
351(a)
BLA number
761484
Applicant
Janssen Biotech, Inc.
Center
CDER
Presentations
4
First licensure
—

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
1,600MG/10ML; 20,000UNITS/10ML (160MG/2,000UNITS/ML) Injection Subcutaneous Single-Dose Vial Rx February 13, 2026
2,240MG/14ML; 28,000UNITS/14ML (160MG/2,000UNITS/ML) Injection Subcutaneous Single-Dose Vial Rx February 13, 2026
2,400MG/15ML; 30,000UNITS (160MG/2,000UNITS/ML) Injection Subcutaneous Single-Dose Vial Rx February 13, 2026
3,520MG/22ML; 44,000UNITS (160MG/2,000UNITS/ML) Injection Subcutaneous Single-Dose Vial Rx February 13, 2026

Sources for this page

Purple Book FDA Licence type, presentations, reference product, exclusivity