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): 125370
Company: HUMAN GENOME SCIENCES INC.

Medication Guide

Summary Review

Products on BLA 125370

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENLYSTA	BELIMUMAB	120MG	INJECTABLE; INJECTION	Prescription	None	No	No
BENLYSTA	BELIMUMAB	400MG	INJECTABLE; INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125370

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/09/2011	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125370s0000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125370s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125370Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125370Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/09/2024	SUPPL-82	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125370s082,761043s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125370Orig1s082; 761043Orig1s028ltr.pdf
02/15/2023	SUPPL-79	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125370s079,761043s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125370Orig1s079;761043Orig1s022ltr.pdf
07/26/2022	SUPPL-78	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125370Orig1s078ltr.pdf
12/16/2020	SUPPL-73	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s073,761043s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125370Orig1s073_761043Orig1s013ltr.pdf
09/24/2020	SUPPL-71	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125370Orig1s071ltr.pdf
01/17/2020	SUPPL-68	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s068,761043s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125370Orig1s068, 761043Orig1s008ltr.pdf
09/13/2019	SUPPL-67	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125370s067,761043s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125370Orig1s067, 761043Orig1s005ltr.pdf
04/26/2019	SUPPL-64	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125370s064,761043s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125370Orig1s064; 761043Orig1s007_REPLACEMENTltr.pdf
06/22/2018	SUPPL-62	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125370s062,761043s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125370Orig1s062_761043Orig1s002 Ltr.pdf
01/18/2017	SUPPL-57	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125370s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125370Orig1s057ltr.pdf
12/02/2016	SUPPL-55	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125370s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125370Orig1s055ltr.pdf
04/03/2014	SUPPL-53	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125370s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125370Orig1s053ltr.pdf
12/13/2013	SUPPL-47	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125370s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125370Orig1s047ltr.pdf
03/30/2012	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125370s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125370s016ltr.pdf

Labels for BLA 125370

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/09/2024	SUPPL-82	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125370s082,761043s028lbl.pdf
02/15/2023	SUPPL-79	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125370s079,761043s022lbl.pdf
12/16/2020	SUPPL-73	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s073,761043s013lbl.pdf
09/24/2020	SUPPL-71	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s071lbl.pdf
01/17/2020	SUPPL-68	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s068,761043s008lbl.pdf
09/13/2019	SUPPL-67	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125370s067,761043s005lbl.pdf
04/26/2019	SUPPL-64	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125370s064,761043s007lbl.pdf
06/22/2018	SUPPL-62	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125370s062,761043s002lbl.pdf
01/18/2017	SUPPL-57	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125370s057lbl.pdf
01/18/2017	SUPPL-57	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125370s057lbl.pdf
12/02/2016	SUPPL-55	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125370s055lbl.pdf
04/03/2014	SUPPL-53	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125370s053lbl.pdf
12/13/2013	SUPPL-47	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125370s047lbl.pdf
03/30/2012	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125370s016lbl.pdf
03/09/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125370s0000lbl.pdf

Top