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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125486
Company: GENENTECH

Office Director Memo

Summary Review

Products on BLA 125486

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GAZYVA	OBINUTUZUMAB	1000MG/40ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125486

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/01/2013	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125486s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125486Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125486Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125486Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/27/2022	SUPPL-34	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125486s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125486Orig1s034ltr.pdf
07/12/2022	SUPPL-33	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125486s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125486Orig1s033ltr.pdf
02/14/2022	SUPPL-29	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125486s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125486Orig1s029ltr.pdf
03/27/2020	SUPPL-25	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125486s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125486Orig1s025ltr.pdf
11/16/2017	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125486s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125486Orig1s017s018ltr.pdf
11/16/2017	SUPPL-17	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125486s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125486Orig1s017s018ltr.pdf
02/26/2016	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125486s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125486Orig1s013ltr.pdf
09/23/2015	SUPPL-10	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125486s010lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125486Orig1s010ltr.pdf
12/24/2014	SUPPL-9	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125486Orig1s009ltr.pdf
06/27/2014	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125486_s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125486Orig1s008ltr.pdf

Labels for BLA 125486

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/27/2022	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125486s034lbl.pdf
07/12/2022	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125486s033lbl.pdf
02/14/2022	SUPPL-29	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125486s029lbl.pdf
03/27/2020	SUPPL-25	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125486s025lbl.pdf
11/16/2017	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125486s017s018lbl.pdf
11/16/2017	SUPPL-17	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125486s017s018lbl.pdf
02/26/2016	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125486s013lbl.pdf
09/23/2015	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125486s010lbledt.pdf
06/27/2014	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125486_s008lbl.pdf
11/01/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125486s000lbl.pdf

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