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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761053
Company: GENENTECH INC

Medication Guide

Products on BLA 761053

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OCREVUS	OCRELIZUMAB	30MG/1ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761053

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/28/2017	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761053Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761053Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/21/2024	SUPPL-35	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761053s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761053Orig1s035ltr.pdf
01/19/2024	SUPPL-34	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761053s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761053Orig1s034ltr.pdf
08/18/2023	SUPPL-31	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761053s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761053Orig1s031ltr.pdf
08/03/2022	SUPPL-30	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761053s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761053Orig1s029, s030ltr.pdf
08/03/2022	SUPPL-29	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761053s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761053Orig1s029, s030ltr.pdf
05/15/2020	SUPPL-24	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s024lbl.pdf
11/06/2020	SUPPL-23	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761053Orig1s023ltr.pdf
12/14/2020	SUPPL-22	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761053Orig1s022ltr.pdf
01/10/2020	SUPPL-20	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761053Orig1s020ltr.pdf
07/16/2019	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761053s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761053Orig1s018ltr.pdf
11/12/2018	SUPPL-12	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761053s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761053Orig1s012ltr.pdf
11/02/2017	SUPPL-8	Supplement		Label is not available on this site.

Labels for BLA 761053

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/21/2024	SUPPL-35	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761053s035lbl.pdf
06/21/2024	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761053s035lbl.pdf
01/19/2024	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761053s034lbl.pdf
08/18/2023	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761053s031lbl.pdf
08/03/2022	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761053s029s030lbl.pdf
08/03/2022	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761053s029s030lbl.pdf
12/14/2020	SUPPL-22	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s022lbl.pdf
11/06/2020	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s023lbl.pdf
05/15/2020	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s024lbl.pdf
01/10/2020	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761053s020lbl.pdf
07/16/2019	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761053s018lbl.pdf
11/12/2018	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761053s012lbl.pdf
03/28/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf

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