An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 125326
Company: NOVARTIS

Medication Guide

Other Important Information from FDA

Summary Review

Products on BLA 125326

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARZERRA	OFATUMUMAB	100MG/5ML	INJECTABLE; INJECTION	Prescription	None	No	No
KESIMPTA	OFATUMUMAB	20MG/0.4ML	SOLUTION;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125326

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/2009	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125326lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125326s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125326s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125326s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/19/2024	SUPPL-80	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125326s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125326Orig1s080ltr.pdf
04/12/2024	SUPPL-79	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125326s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125326Orig1s079ltr.pdf
09/02/2022	SUPPL-75	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125326s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125326Orig1s075ltr.pdf
08/20/2020	SUPPL-70	Supplement	Label (PDF) Letter (PDF) Review (PDF)	Letter, Label, Medication Guide for KESIMPTA	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125326s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125326Orig1s070ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/125326Orig1s070.pdf
08/30/2016	SUPPL-63	Supplement	Label (PDF) Letter (PDF)	Letter, Label for ARZERRA	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125326s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125326Orig1s063ltr.pdf
01/19/2016	SUPPL-62	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125326s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125326Orig1s062ltr.pdf
04/17/2014	SUPPL-60	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125326s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125326Orig1s060ltr.pdf
09/24/2013	SUPPL-59	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125326s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125326Orig1s059ltr.pdf
09/20/2011	SUPPL-32	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125326s0032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125326s0032ltr.pdf
09/23/2010	SUPPL-12	Supplement		Label is not available on this site.

Labels for BLA 125326

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/12/2024	SUPPL-79	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125326s079lbl.pdf
04/12/2024	SUPPL-79	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125326s079lbl.pdf
01/19/2024	SUPPL-80	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125326s080lbl.pdf
01/19/2024	SUPPL-80	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125326s080lbl.pdf
09/02/2022	SUPPL-75	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125326s075lbl.pdf
08/20/2020	SUPPL-70	Efficacy-New Indication	Label (PDF)	Letter, Label, Medication Guide for KESIMPTA	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125326s070lbl.pdf
08/30/2016	SUPPL-63	Efficacy-New Indication	Label (PDF)	Letter, Label for ARZERRA	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125326s063lbl.pdf
01/19/2016	SUPPL-62	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125326s062lbl.pdf
04/17/2014	SUPPL-60	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125326s060lbl.pdf
09/24/2013	SUPPL-59	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125326s059lbl.pdf
09/20/2011	SUPPL-32	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125326s0032lbl.pdf
10/26/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125326lbl.pdf

Top