FDA Approval for BRIUMVI issued to TG THERAPEUTICS, INC
$TGTX
Biotechnology: Pharmaceutical Preparations
Health Care
Biologic License Application (BLA): 761238
Company: TG THERAPEUTICS, INC
Company: TG THERAPEUTICS, INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRIUMVI | UBLITUXIMAB-XIIY | 25 MG/ML | INJECTABLE;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 12/28/2022 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761238s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761238Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761238Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/30/2024 | SUPPL-11 | Supplement |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/28/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761238s000lbl.pdf |