Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761304
Company: ARGENX BV
Company: ARGENX BV
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 |
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.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
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 |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
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 |