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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761304
Company: ARGENX BV

Products on BLA 761304

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VYVGART HYTRULO	EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC	1008MG;11200UNITS PER 5.6ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761304

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/20/2023	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761304s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761304orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761304Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/26/2026	SUPPL-19	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761304s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761304Orig1s019ltr.pdf
05/08/2026	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761195s016lbl761304s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761195Orig1s016; 761304Orig1s018ltr.pdf
10/17/2025	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761304s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761195Orig1s012,761304Orig1s010ltr.pdf
04/10/2025	SUPPL-8	Supplement	Label Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761304Orig1s008lbl https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761304Orig1s008ltr.pdf
06/21/2024	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761304s005,s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761304Orig1s005,s006ltr.pdf
06/21/2024	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761304s005,s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761304Orig1s005,s006ltr.pdf
08/08/2024	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761195s004,761304s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761195Orig1s004;761304Orig1s003ltr.pdf
12/12/2023	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761304s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761304Orig1s002ltr.pdf

Labels for BLA 761304

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/08/2026	SUPPL-18	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761195s016lbl761304s018lbl.pdf
02/26/2026	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761304s019lbl.pdf
10/17/2025	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761304s010lbl.pdf
04/10/2025	SUPPL-8	Efficacy-New Dosing Regimen			https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761304Orig1s008lbl
08/08/2024	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761195s004,761304s003lbl.pdf
06/21/2024	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761304s005,s006lbl.pdf
06/21/2024	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761304s005,s006lbl.pdf
12/12/2023	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761304s002lbl.pdf
06/20/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761304s000lbl.pdf

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