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VYVGART HYTRULO

BLA · Biologics License Application · Sponsor: ARGENX BV · Approved 2023-06-20

Drug application

FDA Application #
BLA761304
Application type
Biologics License Application
Brand name
VYVGART HYTRULO
Generic name
EFGARTIGIMOD ALFA AND HYALURONIDASE (HUMAN RECOMBINANT)
Active ingredients
EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC
Dosage form
INJECTABLE
Route
INJECTION
Marketing status
Prescription
Sponsor
ARGENX BV
Manufacturer
argenx US
First approval
2023-06-20

Source

Authoritative
Drugs@FDA application overview
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