Prescription medicine
Tralokinumab Brand names: Adbry
Tralokinumab (Adbry) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the tralokinumab FDA label on DailyMed (effective December 17, 2025, LEO Pharma Inc.); the BLA 761180 record on Drugs@FDA; every tralokinumab label on DailyMed.
Highlights of the record
FDA label of December 17, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageADBRY is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Forms and strengths
- 150 mg/ml
- 300 mg/2ml
Injection (solution).
On the market
- Earliest approval on file
- December 27, 2021 Adbry, Leo Pharma As; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2026 0 Class I among all firms' recalls; latest February 10, 2026
- FAERS reports
- 6,044 through July 30, 2026
What is tralokinumab used for?
From the label: indications and usageADBRY is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids. ADBRY is an interleukin-13 antagonist indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids.
Conditions named in the indications of tralokinumab's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Interleukin-13 Antagonist.
Source: FDA drug label (Adbry), LEO Pharma Inc., effective December 17, 2025 (SPL set d8020b69-3001-44e2-9b5d-5f93d9aaf6e1), via openFDA; the full label on DailyMed
Is there a generic for tralokinumab (Adbry)?
No generic tralokinumab is approved (Drugs@FDA, October 8, 2026).
- 2021 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has tralokinumab been recalled?
The FDA's Enforcement Report lists 1 recall naming tralokinumab since 2026: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 10, 2026 | Class II | LEO PHARMA INC | Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for tralokinumab?
The FDA Adverse Event Reporting System holds 6,044 reports that list tralokinumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 83 are coded as a death and 315 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (1,894, against a median of 1 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tralokinumab?
3 other medicines are given the same way (subcutaneous) and in the same FDA class as tralokinumab or labeled mainly for the same use (eczema (atopic dermatitis)), the same class first. Eczema (atopic dermatitis) lists all 26 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lebrikizumab | Eczema (atopic dermatitis) | none listed | $1,783.52 per mL 250 mg/2 mL pen | No current entry |
| Dupilumab | Eczema (atopic dermatitis) | none listed | $1,773.74 per mL 200 mg/1.14 mL syring | No current entry |
| Nemolizumab | Eczema (atopic dermatitis) | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as tralokinumab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to tralokinumab
- 3 medicines for the same use
- Other interleukin-13 antagonists
- the pharmacologic class, with prices and generics
- Tralokinumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other