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Vyvgart Hytrulo

efgartigimod alfa and hyaluronidase-qvfc

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Vyvgart Hytrulo

Proper name

efgartigimod alfa and hyaluronidase-qvfc

Licence type

351(a)

BLA number

761304

Applicant

Argenx BV

Center

CDER

Presentations

First licensure

—

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
1,000MG/5ML;10,000UNITS/5ML (200MG/2,000UNITS/ML)	Injection	Subcutaneous	Pre-Filled Syringe	Rx	April 10, 2025
1,008MG/5.6ML; 11,200UNITS/5.6ML (180MG/2,000UNITS/ML)	Injection	Subcutaneous	Single-Dose Vial	Rx	June 20, 2023

Source: Purple Book

Kind	Expires
Orphan exclusivity	June 21, 1931

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