Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125521
Company: ELI LILLY AND CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TALTZ IXEKIZUMAB 80MG/ML 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
03/22/2016 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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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