Treats moderate to severe plaque psoriasis. BLA 761044, held by Janssen Biotech. Ustekinumab.
As of Nov 13, 2026, BLA 761044 (Stelara), held by Janssen Biotech, was first approved by FDA on Sep 23, 2016, with 15 approved supplements and 0 published complete response letters.
Ustekinumab is a human interleukin-12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. Active psoriatic arthritis in adults and pediatric patients 6 years of age and older. Moderately to severely active Crohn's disease in adults and pediatric patients 2 years of age and older. Moderately to severely active ulcerative colitis in adults and pediatric patients 2 years of age and older. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 2026 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Apr 15, 2026 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Oct 18, 2019 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Sep 23, 2016 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Stelara130MG/26ML · injectable;injection | Ustekinumab | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 2026 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Jul 15, 2026 | Supplement 22Labeling · Standard review | Approved | None posted |
| Apr 15, 2026 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Nov 3, 2025 | Supplement 19Labeling · Standard review | Approved | |
| Jun 27, 2025 | Supplement 15Labeling · Standard review | Approved | |
| Apr 1, 2025 | Supplement 16Labeling · Standard review | Approved | |
| Nov 15, 2024 | Supplement 14Labeling · Standard review | Approved | |
| Mar 18, 2024 | Supplement 13Labeling · Standard review | Approved | |
| Mar 6, 2023 | Supplement 9Labeling · Standard review | Approved | |
| Jul 29, 2022 | Supplement 10Labeling · Standard review | Approved | |
| Dec 11, 2020 | Supplement 8Labeling · Standard review | Approved | |
| Dec 1, 2020 | Supplement 6Labeling · Standard review | Approved | |
| Apr 7, 2020 | Supplement 5Labeling · Standard review | Approved | |
| Nov 7, 2019 | Supplement 1Labeling · Standard review | Approved | |
| Oct 18, 2019 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Sep 23, 2016 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
