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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125521
Company: ELI LILLY AND CO

Medication Guide

Summary Review

Products on BLA 125521

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TALTZ	IXEKIZUMAB	80MG/ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125521

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/2016	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125521s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125521Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125521Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125521Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2024	SUPPL-32	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125521s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125521Orig1s032ltr.pdf
11/20/2023	SUPPL-31	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125521Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125521Orig1s031ltr.pdf
09/13/2023	SUPPL-28	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125521Orig1s028ltr.pdf
07/27/2022	SUPPL-24	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125521s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125521Orig1s024ltr.pdf
05/04/2022	SUPPL-23	Supplement		Label is not available on this site.
03/26/2020	SUPPL-20	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125521s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125521Orig1s020ltr.pdf
05/29/2020	SUPPL-19	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125521s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125521Orig1s019ltr.pdf
08/23/2019	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125521s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125521Orig1s016ltr.pdf
03/10/2021	SUPPL-14	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125521s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125521Orig1s014ltr.pdf
03/16/2018	SUPPL-11	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125521Orig1s011ltr.pdf
05/17/2018	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125521s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125521Orig1s009ltr.pdf
12/01/2017	SUPPL-4	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125521s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125521Orig1s004ltr.pdf
07/05/2017	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125521s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125521Orig1s003ltr.pdf
04/19/2018	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125521Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125521Orig1s002ltr.pdf

Labels for BLA 125521

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2024	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125521s032lbl.pdf
08/20/2024	SUPPL-32	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125521s032lbl.pdf
11/20/2023	SUPPL-31	Tentative Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125521Orig1s031lbl.pdf
07/27/2022	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125521s024lbl.pdf
07/27/2022	SUPPL-24	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125521s024lbl.pdf
03/10/2021	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125521s014lbl.pdf
05/29/2020	SUPPL-19	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125521s019lbl.pdf
03/26/2020	SUPPL-20	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125521s020lbl.pdf
08/23/2019	SUPPL-16	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125521s016lbl.pdf
05/17/2018	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125521s009lbl.pdf
04/19/2018	SUPPL-2		Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125521Orig1s002lbl.pdf
12/01/2017	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125521s004lbl.pdf
07/05/2017	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125521s003lbl.pdf
03/22/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125521s000lbl.pdf

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