Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125319
Company: NOVARTIS PHARMS
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 |
---|---|---|---|---|---|
08/25/2023 | SUPPL-107 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125319s107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125319Orig1s107ltr.pdf | |
09/18/2020 | SUPPL-100 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125319s100lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125319Orig1s100ltr.pdf | |
06/16/2020 | SUPPL-97 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125319s097lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125319Orig1s097ltr.pdf | |
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 |
---|---|---|---|---|---|
08/25/2023 | SUPPL-107 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125319s107lbl.pdf | |
09/18/2020 | SUPPL-100 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125319s100lbl.pdf | |
06/16/2020 | SUPPL-97 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125319s097lbl.pdf | |
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 |