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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125472
Company: GENENTECH

Medication Guide

Summary Review

Products on BLA 125472

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACTEMRA	TOCILIZUMAB	162MG/0.9ML	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125472

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/21/2013	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125472s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125472Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125472Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125472Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2022	SUPPL-49	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125472s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125472Orig1s049ltr.pdf
02/28/2022	SUPPL-46	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125472s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125472Orig1s046ltr.pdf
10/22/2021	SUPPL-45	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125472Orig1s045, 125276Orig1s135ltr.pdf
03/04/2021	SUPPL-44	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125472s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125472Orig1s044ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/125472Orig1s044.pdf
05/28/2020	SUPPL-42	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125276s129,125472s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125472Orig1s042,125276Orig1s129ltr.pdf
06/11/2019	SUPPL-40	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125276s127,125472s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125276Orig1s127; 125472Orig1s040ltr.pdf
12/20/2018	SUPPL-38	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s125,125472s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125472Orig1s038Ltr.pdf
04/11/2019	SUPPL-37	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125472s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125472Orig1s037ltr.pdf
05/17/2018	SUPPL-32	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s117,125472s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125276Orig1s117,125472Orig1s032ltr.pdf
09/12/2018	SUPPL-31	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s122,125472s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125472Orig1s031,125276Orig1s122Ltr.pdf
03/22/2018	SUPPL-30	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s116,125472s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125276Orig1s116,125472Orig1s030ltr.pdf
11/19/2018	SUPPL-29	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s118,125472s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125472Orig1s029,125276Orig1s118ltr.pdf
05/11/2018	SUPPL-28	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s115,125472s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125276Orig1s115,125472Orig1s028ltr.pdf
05/22/2017	SUPPL-24	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125472s024lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125472Orig1s024ltr.pdf
03/30/2017	SUPPL-23	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s111,125472s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125276Orig1s111,125472Orig1s023ltr.pdf
09/23/2016	SUPPL-18	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125276s107_125472s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125276Orig1s107,125472Orig1s018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125472Orig1s018.pdf
08/18/2015	SUPPL-14	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125276s106,125472s014ltr.pdf

Labels for BLA 125472

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2022	SUPPL-49	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125472s049lbl.pdf
02/28/2022	SUPPL-46	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125472s046lbl.pdf
02/28/2022	SUPPL-46	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125472s046lbl.pdf
03/04/2021	SUPPL-44	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125472s044lbl.pdf
05/28/2020	SUPPL-42	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125276s129,125472s042lbl.pdf
05/28/2020	SUPPL-42	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125276s129,125472s042lbl.pdf
05/28/2020	SUPPL-42	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125276s129,125472s042lbl.pdf
06/11/2019	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125276s127,125472s040lbl.pdf
04/11/2019	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125472s037lbl.pdf
12/20/2018	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s125,125472s038lbl.pdf
11/19/2018	SUPPL-29	Efficacy-Manufacturing Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s118,125472s029lbl.pdf
09/12/2018	SUPPL-31	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s122,125472s031lbl.pdf
05/17/2018	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s117,125472s032lbl.pdf
05/11/2018	SUPPL-28	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s115,125472s028lbl.pdf
03/22/2018	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125276s116,125472s030lbl.pdf
05/22/2017	SUPPL-24	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125472s024lbledt.pdf
03/30/2017	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125276s111,125472s023lbl.pdf
09/23/2016	SUPPL-18	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125276s107_125472s018lbl.pdf
10/21/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125472s000lbl.pdf

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