Quick answers
- What is Ustekinumab-aekn used for?
- The FDA-approved label (Selarsdi, Teva Pharmaceuticals USA, Inc., June 24, 2026) says: “SELARSDI is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. active psoriatic arthritis (PsA). moderately to severely active Crohn’s disease (CD). moderately to severely active ulcerative colitis. Pediatric patients 6 years and older with …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ustekinumab-aekn have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ustekinumab-aekn?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ustekinumab-aekn been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ustekinumab-aekn?
- 1 company lists prescription products of Ustekinumab-aekn in the FDA NDC Directory, including Teva Pharmaceuticals USA, Inc..
What Ustekinumab-aekn is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SELARSDI is a human interleukin-12 and -23 antagonist indicated for the treatment of: Adult patients with: moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy. active psoriatic arthritis (PsA). moderately to severely active Crohn’s disease (CD). moderately to severely active ulcerative colitis. Pediatric patients 6 years and older with …
— FDA label: Selarsdi, Teva Pharmaceuticals USA, Inc., effective June 24, 2026. Read the full label on DailyMed →
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous · Intravenous |
| Prescription products | 7 in the FDA NDC Directory |
| Brand names | Selarsdi |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Teva Pharmaceuticals USA, Inc.7 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761343 SELARSDI | Alvotech USA Inc | April 16, 2024 | 7, latest December 1, 2025 2025: BIOSIMILAR · 2025: Labeling · 2025: Supplement |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Selarsdi, Teva Pharmaceuticals USA, Inc., effective June 24, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →