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Biologic License Application (BLA): 125377
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
YERVOY IPILIMUMAB 3MG INJECTABLE; INJECTION Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/25/2011 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125377s0000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125377s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125377Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125377Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/23/2022 SUPPL-130 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s130lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125377Orig1s130ltr.pdf
02/15/2023 SUPPL-129 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125377s129lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125377Orig1s129ltr.pdf
02/25/2022 SUPPL-127 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s127lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125377Orig1s127ltr.pdf
02/25/2022 SUPPL-126 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s126lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125377Orig1s126ltr.pdf
05/11/2022 SUPPL-124 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s124lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125377Orig1s124ltr.pdf
05/27/2022 SUPPL-122 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s122lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125377Orig1s122ltr.pdf
05/25/2021 SUPPL-121 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125377s121lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125377Orig1s121ltr.pdf
11/13/2020 SUPPL-119 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s119lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125377Orig1s119ltr.pdf
10/02/2020 SUPPL-115 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s115lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125377Orig1s115ltr.pdf
09/18/2020 SUPPL-112 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s112lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125377Orig1s112ltr.pdf
08/13/2020 SUPPL-111 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s111lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125377Orig1s111ltr.pdf
05/26/2020 SUPPL-110 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s110lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125377Orig1s110ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/125377Orig1s110_125554Orig1s082.pdf
05/15/2020 SUPPL-109 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s109lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125377Orig1s109ltr.pdf
03/10/2020 SUPPL-108 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125377Orig1s108ltr.pdf
06/29/2020 SUPPL-106 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s106lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125377Orig1s106ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/125377Orig1s106.pdf
09/20/2019 SUPPL-104 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125377s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125377Orig1s104ltr.pdf
05/08/2019 SUPPL-102 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125377s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125377Orig1s102ltr.pdf
07/10/2018 SUPPL-96 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125377Orig1s096ltr.pdf
04/16/2018 SUPPL-94 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s094lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125377Orig1s094ltr.pdf
02/08/2018 SUPPL-93 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s093lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125377Orig1s093ltr.pdf
12/13/2017 SUPPL-91 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125377Orig1s091ltr.pdf
07/21/2017 SUPPL-87 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125377Orig1s087ltr.pdf
10/20/2017 SUPPL-86 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125377Orig1s086ltr.pdf
03/03/2017 SUPPL-84 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125377Orig1s084ltr.pdf
08/17/2015 SUPPL-74 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125377Orig1s074ltr.pdf
10/28/2015 SUPPL-73 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125377Orig1s073ltr.pdf
03/19/2015 SUPPL-72 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125377Orig1s072ltr.pdf
03/16/2015 SUPPL-71 Supplement

Label is not available on this site.

12/05/2013 SUPPL-55 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125377s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125377Orig1s055ltr.pdf
05/22/2013 SUPPL-44 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125377s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125377Orig1s044ltr.pdf
10/26/2012 SUPPL-33 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125377s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125377Orig1s033ltr.pdf
02/16/2012 SUPPL-16 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125377s016ltr.pdf
07/28/2011 SUPPL-8 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/15/2023 SUPPL-129 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125377s129lbl.pdf
11/23/2022 SUPPL-130 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s130lbl.pdf
11/23/2022 SUPPL-130 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s130lbl.pdf
05/27/2022 SUPPL-122 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s122lbl.pdf
05/11/2022 SUPPL-124 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s124lbl.pdf
02/25/2022 SUPPL-127 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s127lbl.pdf
02/25/2022 SUPPL-126 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s126lbl.pdf
05/25/2021 SUPPL-121 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125377s121lbl.pdf
11/13/2020 SUPPL-119 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s119lbl.pdf
10/02/2020 SUPPL-115 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s115lbl.pdf
09/18/2020 SUPPL-112 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s112lbl.pdf
08/13/2020 SUPPL-111 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s111lbl.pdf
06/29/2020 SUPPL-106 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s106lbl.pdf
05/26/2020 SUPPL-110 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s110lbl.pdf
05/15/2020 SUPPL-109 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s109lbl.pdf
03/10/2020 SUPPL-108 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s108lbl.pdf
09/20/2019 SUPPL-104 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125377s104lbl.pdf
05/08/2019 SUPPL-102 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125377s102lbl.pdf
07/10/2018 SUPPL-96 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s096lbl.pdf
04/16/2018 SUPPL-94 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s094lbl.pdf
02/08/2018 SUPPL-93 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s093lbl.pdf
12/13/2017 SUPPL-91 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s091lbl.pdf
10/20/2017 SUPPL-86 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s086lbl.pdf
07/21/2017 SUPPL-87 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s087lbl.pdf
10/28/2015 SUPPL-73 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s073lbl.pdf
08/17/2015 SUPPL-74 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s074lbl.pdf
08/17/2015 SUPPL-74 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s074lbl.pdf
03/19/2015 SUPPL-72 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s072lbl.pdf
12/05/2013 SUPPL-55 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125377s055lbl.pdf
05/22/2013 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125377s044lbl.pdf
10/26/2012 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125377s033lbl.pdf
03/25/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125377s0000lbl.pdf
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