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FDA Drug/Biologics Approval BLA 761304, EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC
FDA Drug/Biologics Approval BLA 761304, EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC
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BLA 761304
Company: ARGENX BV
Drug Name: VYVGART HYTRULO
Active Ingredients: EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC
Strength: 1008MG;11200UNITS PER 5.6ML
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 06/20/2023
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: ARGENX BV
Drug Name: VYVGART HYTRULO
Active Ingredients: EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC
Strength: 1008MG;11200UNITS PER 5.6ML
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 06/20/2023
Marketing Status: Prescription
Submission Classification: ORIG-1
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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