BRIUMVI
BLA 761238 · Biologics License Application (BLA) Prescription
UBLITUXIMAB-XIIY
- Sponsor (Drugs@FDA)
- TG THERAPEUTICS, INC Company: TG THERAPEUTICS, INC. (TGTX)
- 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 | BRIUMVI UBLITUXIMAB-XIIY | INJECTABLE;INTRAVENOUS 25 MG/ML | Prescription | – | No | Not listed |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 26 | Approved | standard | Labeling | Letter for Supplement 26 (opens in a new tab)Label for Supplement 26 (opens in a new tab) | |
| Supplement 22 | Approved | standard | Labeling | Letter for Supplement 22 (opens in a new tab) | |
| Supplement 25 | Approved | standard | Labeling | Letter for Supplement 25 (opens in a new tab)Label for Supplement 25 (opens in a new tab) | |
| Supplement 11 | Approved | standard | Labeling | Letter for Supplement 11 (opens in a new tab)Label for Supplement 11 (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 |
|---|---|---|---|---|---|---|
| Briumvi 001ublituximab-xiiy · TG Therapeutics, Inc. | 351(a) Licensed · Rx | 150MG/6ML (25MG/ML) Injection · Intravenous · Single-Dose Vial | – | – | – |
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.
BRIUMVI
UBLITUXIMAB · TG Therapeutics, Inc. · INTRAVENOUS · Version 21 · effective
Indications and usage
1 INDICATIONS AND USAGE BRIUMVI is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BRIUMVI is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 , 14 ).
NDC products
1 product in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 73150-150 in openFDA (opens in a new tab) | BRIUMVI ublituximab | TG Therapeutics, Inc. | INJECTION, SOLUTION, CONCENTRATE 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.