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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761049
Company: EMD SERONO INC

Medication Guide

Products on BLA 761049

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BAVENCIO	AVELUMAB	20MG/ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761049

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/23/2017	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761049Orig1s000ltredt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761049Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/06/2024	SUPPL-16	Supplement	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761049s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761049Orig1s016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761049Origs016ltr.pdf
09/06/2023	SUPPL-15	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761049s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761049Orig1s015ltr.pdf
07/15/2022	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761049s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761049Orig1s013ltr.pdf
06/30/2020	SUPPL-9	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761049Orig1s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761049Orig1s009.pdf
05/14/2019	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761049s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761049Orig1s006ltr.pdf
11/10/2020	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761049Orig1s005ltr.pdf
10/19/2018	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761049s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761049Orig1s003ltr.pdf
10/12/2017	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761049Orig1s002ltr.pdf
04/25/2017	SUPPL-1	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761049Orig1s001ltr.pdf

Labels for BLA 761049

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/06/2024	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761049s016lbl.pdf
09/06/2023	SUPPL-15	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761049s015lbl.pdf
07/15/2022	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761049s013lbl.pdf
11/10/2020	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s005lbl.pdf
11/10/2020	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s005lbl.pdf
06/30/2020	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s009lbl.pdf
05/14/2019	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761049s006lbl.pdf
10/19/2018	SUPPL-3	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761049s003lbl.pdf
10/12/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s002lbl.pdf
03/23/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761049s000lbl.pdf

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