Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125319
Company: NOVARTIS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ILARIS CANAKINUMAB 180MG INJECTABLE; SUBCUTANEOUS 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
06/17/2009 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125319s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125319s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125319s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125319s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/22/2016 SUPPL-88 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125319s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125319Orig1s088ltr.pdf
09/23/2016 SUPPL-87 Supplement Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/BLA125319_858687lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125319Orig1s085,s086,s087ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125319Orig1s085,086,087TOC.cfm
09/23/2016 SUPPL-86 Supplement Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/BLA125319_858687lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125319Orig1s085,s086,s087ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125319Orig1s085,086,087TOC.cfm
09/23/2016 SUPPL-85 Supplement Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/BLA125319_858687lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125319Orig1s085,s086,s087ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125319Orig1s085,086,087TOC.cfm
07/21/2016 SUPPL-84 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125319s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125319Orig1s084ltr.pdf
10/16/2014 SUPPL-81 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125319s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125319Orig1s081ltr.pdf
05/09/2013 SUPPL-62 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125319s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125319Orig1s062ltr_repl.pdf
10/11/2012 SUPPL-54 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125319s0054.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125319Orig1s054ltr.pdf
03/30/2012 SUPPL-47 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125319s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125319s047ltr.pdf
11/17/2011 SUPPL-14 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/22/2016 SUPPL-88 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125319s088lbl.pdf
09/23/2016 SUPPL-87 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/BLA125319_858687lbl.pdf
09/23/2016 SUPPL-86 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/BLA125319_858687lbl.pdf
09/23/2016 SUPPL-85 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/BLA125319_858687lbl.pdf
07/21/2016 SUPPL-84 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125319s084lbl.pdf
10/16/2014 SUPPL-81 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125319s081lbl.pdf
05/09/2013 SUPPL-62 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125319s062lbl.pdf
10/11/2012 SUPPL-54 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125319s0054.pdf
03/30/2012 SUPPL-47 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125319s047lbl.pdf
06/17/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125319s000lbl.pdf

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