Treats moderate to severe plaque psoriasis. BLA 761364, held by Accord Biopharma Inc.. Ustekinumab-Srlf.
As of Nov 13, 2026, BLA 761364 (Imuldosa), held by Accord Biopharma Inc., was first approved by FDA on Oct 10, 2024, with 3 approved supplements and 0 published complete response letters.
IMULDOSA is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: 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 adult and pediatric patients 6 years of age and older. moderately to severely active Crohn’s disease in adult patients. moderately to severely active ulcerative colitis in adult patients. 1.1 Plaque Psoriasis (PsO) IMULDOSA is indicated for the treatment of adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 10, 2024 | Original applicationNew active ingredient · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Imuldosa45MG/0.5ML · injectable;intravenous | Ustekinumab-Srlf | Rx |
| Imuldosa90MG/ML · injectable;intravenous | Ustekinumab-Srlf | Rx |
| Imuldosa130MG/26ML · injectable;intravenous | Ustekinumab-Srlf | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 5, 2026 | Supplement 5Bioequivalence | Approved | |
| Nov 20, 2025 | Supplement 3Labeling · Standard review | Approved | |
| Mar 17, 2025 | Supplement 1Labeling · Standard review | Approved | |
| Oct 10, 2024 | Original applicationNew active ingredient · 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
