FDA Approval for SKYRIZI issued to ABBVIE INC
$ABBV
Biotechnology: Pharmaceutical Preparations
Health Care
Biologic License Application (BLA): 761262
Company: ABBVIE INC
Company: ABBVIE INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SKYRIZI | RISANKIZUMAB-RZAA | 600MG/VIAL | INJECTABLE;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 06/16/2022 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761262s000lblUpdated.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761262Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761262Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/04/2024 | SUPPL-8 | 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 | |
| 06/18/2024 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761105s029,761262s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761105Orig1s029;761262Orig1s007ltr.pdf | |
| 01/03/2024 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761262s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761262Orig1s005;761105Orig1s032ltr.pdf | |
| 09/23/2022 | SUPPL-1 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761262s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761262Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/18/2024 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761105s029,761262s007lbl.pdf | |
| 03/04/2024 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761105s027,761262s008lbl.pdf | |
| 01/03/2024 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761262s005lbl.pdf | |
| 09/23/2022 | SUPPL-1 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761262s001lbl.pdf | |
| 09/23/2022 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761262s001lbl.pdf | |
| 06/16/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761262s000lblUpdated.pdf |