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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761238
Company: TG THERAPEUTICS, INC

Medication Guide

Products on BLA 761238

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761238

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.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/16/2026	SUPPL-26	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761238s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761238Orig1s026ltr.pdf
08/18/2025	SUPPL-25	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761238s022s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761238Orig1s022, s025ltr.pdf
08/18/2025	SUPPL-22	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761238Orig1s022, s025ltr.pdf
10/30/2024	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761238s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761238Orig1s011ltr.pdf

Labels for BLA 761238

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/16/2026	SUPPL-26	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761238s026lbl.pdf
01/16/2026	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761238s026lbl.pdf
08/18/2025	SUPPL-25	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761238s022s025lbl.pdf
08/18/2025	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761238s022s025lbl.pdf
10/30/2024	SUPPL-11	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761238s011lbl.pdf
10/30/2024	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761238s011lbl.pdf
12/28/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761238s000lbl.pdf

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