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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125431
Company: GLAXOSMITHKLINE LLC

Medication Guide

REMS

Summary Review

Products on BLA 125431

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TANZEUM	ALBIGLUTIDE	30MG	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125431

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/15/2014	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125431s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125431Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125431Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125431Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/12/2017	SUPPL-21	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125431Orig1s021ltr.pdf
12/20/2017	SUPPL-20	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125431Orig1s020ltr.pdf
08/01/2017	SUPPL-19	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125431Orig1s019ltr.pdf
09/13/2016	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125431s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125431Orig1s018ltr.pdf
07/27/2015	SUPPL-14	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125431Orig1s014ltr.pdf
05/07/2015	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125431s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125431Orig1s009ltr.pdf
03/09/2015	SUPPL-8	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125431Orig1s008ltr.pdf

Labels for BLA 125431

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2017	SUPPL-20	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s020lbl.pdf
12/20/2017	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s020lbl.pdf
08/01/2017	SUPPL-19	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s019lbl.pdf
08/01/2017	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s019lbl.pdf
09/13/2016	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125431s018lbl.pdf
05/07/2015	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125431s009lbl.pdf
04/15/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125431s000lbl.pdf

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