FDA Approval for SKYRIZI issued to ABBVIE INC
$ABBV
Biotechnology: Pharmaceutical Preparations
Health Care
Biologic License Application (BLA): 761105
Company: ABBVIE INC
Company: ABBVIE INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SKYRIZI | RISANKIZUMAB-RZAA | 75MG/0.83ML | INJECTABLE;INJECTION | Prescription | None | No | No |
| SKYRIZI | RISANKIZUMAB-RZAA | 150MG/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 |
|---|---|---|---|---|---|---|---|
| 04/23/2019 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761105s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761105s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761105Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/03/2024 | SUPPL-32 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761105s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761262Orig1s005;761105Orig1s032ltr.pdf | |
| 06/18/2024 | SUPPL-29 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761105Orig1s029;761262Orig1s007ltr.pdf |
| 03/04/2024 | SUPPL-27 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761105s027,761262s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761105Orig1s027; 761262Orig1s008ltr.pdf | |
| 09/23/2022 | SUPPL-18 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761105Orig1s018ltr.pdf | |
| 06/16/2022 | SUPPL-16 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761105Orig1s016ltr.pdf | |
| 01/21/2022 | SUPPL-14 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761105Orig1s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761105Orig1s014.pdf | |
| 04/26/2021 | SUPPL-10 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761105s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761105Orig1s009, s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761105Orig1s009,s010.pdf | |
| 04/26/2021 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761105s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761105Orig1s009, s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761105Orig1s009,s010.pdf | |
| 03/20/2020 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761105s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761105Orig1s005ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/04/2024 | SUPPL-27 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761105s027,761262s008lbl.pdf | |
| 01/03/2024 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761105s032lbl.pdf | |
| 09/23/2022 | SUPPL-18 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s018lbl.pdf | |
| 06/16/2022 | SUPPL-16 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s016lbl.pdf | |
| 01/21/2022 | SUPPL-14 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761105s014lbl.pdf | |
| 04/26/2021 | SUPPL-10 | Efficacy-Manufacturing Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761105s009s010lbl.pdf | |
| 04/26/2021 | SUPPL-9 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761105s009s010lbl.pdf | |
| 03/20/2020 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761105s005lbl.pdf | |
| 04/23/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761105s000lbl.pdf |