Drugs@FDA: FDA-Approved Drugs
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.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/18/2026 | SUPPL-17 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761262s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761105Orig1s047,761262Orig1s017ltr.pdf | |
| 03/06/2026 | SUPPL-14 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761262s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761105Orig1s042,761262Orig1s014ltr.pdf | |
| 09/03/2025 | SUPPL-11 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761105s039,761262s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761105Orig1s039, 761262Orig1s011ltr.pdf | |
| 05/07/2025 | SUPPL-10 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761262Orig1s010; 761105Orig1s038ltr.pdf |
| 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 |
|---|---|---|---|---|---|
| 03/18/2026 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761262s017lbl.pdf | |
| 03/18/2026 | SUPPL-17 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761262s017lbl.pdf | |
| 03/06/2026 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761262s014lbl.pdf | |
| 09/03/2025 | SUPPL-11 | Efficacy-Manufacturing Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761105s039,761262s011lbl.pdf | |
| 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761262s001lbl.pdf | |
| 09/23/2022 | SUPPL-1 | Labeling-Medication Guide | 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 |