Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125504
Company: NOVARTIS PHARMS CORP
Company: NOVARTIS PHARMS CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COSENTYX | SECUKINUMAB | 150MG/ML | INJECTABLE;INJECTION | Prescription | TBD | TBD | 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 |
|---|---|---|---|---|---|---|---|
| 01/21/2015 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125504s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125504Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125504Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125504Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/16/2024 | SUPPL-82 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125504s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125504Orig1s082ltr.pdf | |
| 10/06/2023 | SUPPL-73 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125504Orig1s073ltr.pdf | |
| 07/24/2023 | SUPPL-67 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504Orig1s054s055s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125504Orig1s054;s055;s067ltr.pdf | |
| 11/21/2023 | SUPPL-66 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504s066,761349s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125504Orig1s066; 761349Orig1s004ltr.pdf | |
| 10/31/2023 | SUPPL-63 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125504Orig1s063ltr.pdf | |
| 07/24/2023 | SUPPL-55 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504Orig1s054s055s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125504Orig1s054;s055;s067ltr.pdf | |
| 07/24/2023 | SUPPL-54 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504Orig1s054s055s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125504Orig1s054;s055;s067ltr.pdf | |
| 12/22/2021 | SUPPL-51 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125504_S050_S051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125504Orig1s050, s051ltr.pdf | |
| 12/22/2021 | SUPPL-50 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125504_S050_S051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125504Orig1s050, s051ltr.pdf | |
| 05/11/2023 | SUPPL-44 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125504Orig1s044ltr.pdf | |
| 05/28/2021 | SUPPL-43 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125504s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125504Orig1s043ltr.pdf | |
| 06/16/2020 | SUPPL-35 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125504s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125504Orig1s035ltr.pdf | |
| 01/29/2020 | SUPPL-31 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125504s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125504Orig1s031ltr.pdf | |
| 09/15/2017 | SUPPL-16 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125504s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125504Orig1s016ltr.pdf | |
| 01/23/2018 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125504s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125504Orig1s013ltr.pdf | |
| 06/19/2018 | SUPPL-5 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125504Orig1s005ltr.pdf |
| 01/15/2016 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125504s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125504Orig1s001,s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/125504Orig1s002.pdf | |
| 01/15/2016 | SUPPL-1 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125504s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125504Orig1s001,s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/125504Orig1s001.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/16/2024 | SUPPL-82 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125504s082lbl.pdf | |
| 11/21/2023 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504s066,761349s004lbl.pdf | |
| 10/31/2023 | SUPPL-63 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504s063lbl.pdf | |
| 10/06/2023 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504s073lbl.pdf | |
| 07/24/2023 | SUPPL-67 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504Orig1s054s055s067lbl.pdf |
| 07/24/2023 | SUPPL-55 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504Orig1s054s055s067lbl.pdf | |
| 07/24/2023 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504Orig1s054s055s067lbl.pdf | |
| 07/24/2023 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504Orig1s054s055s067lbl.pdf | |
| 05/11/2023 | SUPPL-44 | Efficacy-Manufacturing Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504s044lbl.pdf | |
| 12/22/2021 | SUPPL-51 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125504_S050_S051lbl.pdf | |
| 12/22/2021 | SUPPL-50 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125504_S050_S051lbl.pdf | |
| 05/28/2021 | SUPPL-43 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125504s043lbl.pdf | |
| 06/16/2020 | SUPPL-35 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125504s035lbl.pdf | |
| 01/29/2020 | SUPPL-31 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125504s031lbl.pdf | |
| 01/23/2018 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125504s013lbl.pdf | |
| 09/15/2017 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125504s016lbl.pdf | |
| 09/15/2017 | SUPPL-16 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125504s016lbl.pdf | |
| 01/15/2016 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125504s001s002lbl.pdf | |
| 01/15/2016 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125504s001s002lbl.pdf | |
| 01/21/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125504s000lbl.pdf |
COSENTYX
There are no Therapeutic Equivalents.