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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125557
Company: AMGEN

Medication Guide

Products on BLA 125557

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BLINCYTO	BLINATUMOMAB	35MCG	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125557

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/03/2014	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125557lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125557Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125557Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/08/2024	SUPPL-29	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125557s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125557Orig1s029ltr.pdf
06/14/2024	SUPPL-28	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125557Orig1s028Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125557Orig1s028Correctedltr.pdf
06/20/2023	SUPPL-26	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125557s023s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125557Orig1s023,s026ltr.pdf
12/05/2022	SUPPL-25	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125557Orig1s025ltr.pdf
06/20/2023	SUPPL-23	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125557s023s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125557Orig1s023,s026ltr.pdf
02/18/2022	SUPPL-21	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125557s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125557Orig1s021ltr.pdf
03/11/2021	SUPPL-20	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125557s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125557Orig1s020ltr.pdf
03/11/2021	SUPPL-19	Supplement		Label is not available on this site.
03/11/2021	SUPPL-18	Supplement		Label is not available on this site.
03/20/2020	SUPPL-17	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125557s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125557Orig1s017ltr.pdf
04/18/2019	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125557s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125557Orig1s015, s016ltr.pdf
04/18/2019	SUPPL-15	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125557s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125557Orig1s015, s016ltr.pdf
04/10/2018	SUPPL-14	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125557Orig1s014ltr.pdf
03/29/2018	SUPPL-13	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125557s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125557Orig1s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125557Orig1s013.pdf
11/30/2017	SUPPL-12	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125557Orig1s012ltr.pdf
07/11/2017	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125557Orig1s008ltr.pdf
05/03/2017	SUPPL-7	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125557Orig1s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/125557Orig1s007.pdf
08/30/2016	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125557Orig1s005,s006ltr.pdf
08/30/2016	SUPPL-5	Supplement	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125557Orig1s005,s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125557Orig1s005TOC.cfm

Labels for BLA 125557

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/14/2024	SUPPL-28	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125557Orig1s028Correctedlbl.pdf
02/08/2024	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125557s029lbl.pdf
06/20/2023	SUPPL-26	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125557s023s026lbl.pdf
06/20/2023	SUPPL-23	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125557s023s026lbl.pdf
02/18/2022	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125557s021lbl.pdf
03/11/2021	SUPPL-20	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125557s020lbl.pdf
03/20/2020	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125557s017lbl.pdf
04/18/2019	SUPPL-16	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125557s015s016lbl.pdf
04/18/2019	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125557s015s016lbl.pdf
03/29/2018	SUPPL-13	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125557s013lbl.pdf
11/30/2017	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s012lbl.pdf
07/11/2017	SUPPL-8	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s008lbl.pdf
05/03/2017	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s007lbl.pdf
05/03/2017	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s007lbl.pdf
08/30/2016	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf
08/30/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf
08/30/2016	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf
12/03/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125557lbl.pdf

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