VYVGART
BLA 761195 · Biologics License Application (BLA) Prescription
EFGARTIGIMOD ALFA
- Sponsor (Drugs@FDA)
- ARGENX BV Company: ARGENX SE (ARGX)
- First approved
- Latest action
Drugs on HealthTrade
Drugs whose FDA actions or confirmed applications cite this number. A drug listed from this record shows “Not yet reviewed” on its page until an editor checks it.
Products
| Product | Name and ingredient | Form and strength | Marketing status | TE code | Reference | Orange Book |
|---|---|---|---|---|---|---|
| 001 | VYVGART EFGARTIGIMOD ALFA | INJECTABLE;INJECTION 400MG | Prescription | – | No | Not listed |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 16 | Approved | priority | Efficacy | Letter for Supplement 16 (opens in a new tab)Label for Supplement 16 (opens in a new tab) | |
| Supplement 12 | Approved | standard | Efficacy | Letter for Supplement 12 (opens in a new tab)Label for Supplement 12 (opens in a new tab) | |
| Supplement 4 | Approved | standard | Efficacy | Letter for Supplement 4 (opens in a new tab)Label for Supplement 4 (opens in a new tab) | |
| Supplement 6 | Approved | standard | Labeling | Letter for Supplement 6 (opens in a new tab)Label for Supplement 6 (opens in a new tab) | |
| Supplement 3 | Approved | standard | Labeling | Letter for Supplement 3 (opens in a new tab)Label for Supplement 3 (opens in a new tab) | |
| Original 1 | Approved | standard | Type 1 - New Molecular Entity | Letter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab) |
Orange Book patents
No Orange Book patents are listed for this application.
Orange Book exclusivities
No Orange Book exclusivities are listed for this application.
Purple Book licensure
| Product | Licence | Strength and presentation | Licensed on | First licensure | Reference product | Exclusivity |
|---|---|---|---|---|---|---|
| Vyvgart 001efgartigimod alfa-fcab · Argenx BV | 351(a) Licensed · Rx | 400MG/20ML (20MG/ML) Injection · Intravenous · Single-Dose Vial | – | – | Orphan exclusivity expires |
Prescription labels
The latest version of each DailyMed label, newest first. Indications and boxed warnings are cut to 1,000 characters; DailyMed has the full label.
VYVGART
EFGARTIGIMOD ALFA · argenx US · INTRAVENOUS · Version 15 · effective
Indications and usage
1 INDICATIONS AND USAGE VYVGART is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG). VYVGART is a neonatal Fc receptor blocker indicated for the treatment of adult patients with generalized myasthenia gravis (gMG). ( 1 )
NDC products
1 product in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 73475-3041 in openFDA (opens in a new tab) | VYVGART EFGARTIGIMOD ALFA | argenx US | INJECTION INTRAVENOUS | BLA | From |
FDA recalls load here.
FDA drug shortages load here.
Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-10-25.
- Purple Book (opens in a new tab)Licence: public-domain. Purple Book purplebook-2026-09.csv.
- openFDA drug labels (DailyMed SPL) (opens in a new tab)Licence: cc0. openFDA drug label download 2026-10-25.
- openFDA NDC directory (opens in a new tab)Licence: cc0. openFDA NDC download 2026-10-25.
Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”
Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.