Quick answers
- What is Brodalumab used for?
- The FDA-approved label (Siliq, Bausch Health US LLC, May 28, 2026) says: “SILIQ ® (brodalumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Brodalumab have a boxed warning?
- Yes. The FDA label for Siliq has a boxed warning (“WARNING: SUICIDAL IDEATION AND BEHAVIOR”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Brodalumab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Brodalumab been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Brodalumab?
- 1 company lists prescription products of Brodalumab in the FDA NDC Directory, including Bausch Health US, LLC.
What Brodalumab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SILIQ ® (brodalumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. …
— FDA label: Siliq, Bausch Health US LLC, effective May 28, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SUICIDAL IDEATION AND BEHAVIOR
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Subcutaneous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Siliq |
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.
- Bausch Health US, LLC1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761032 SILIQ | Valeant Luxembourg | February 15, 2017 | 10, latest May 7, 2026 2026: REMS · 2026: REMS · 2024: Labeling |
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
| RxCUI (RxNorm) | 1872256, 1872261 |
|---|---|
| SPL set ID of the quoted label | 1a550c33-456a-4833-814e-8591aea7c688 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761032 |
| Active ingredients (FDA) | BRODALUMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Siliq, Bausch Health US LLC, effective May 28, 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 →