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Prescription medicine

Tralokinumab-ldrm

Brand names: Adbry

Drug class: Interleukin-13 Antagonist

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
1Recalls (FDA reports)
1Companies
2021First FDA approval on file

Quick answers

What is Tralokinumab-ldrm used for?
The FDA-approved label (Adbry, LEO Pharma Inc., December 17, 2025) says: “ADBRY 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Tralokinumab-ldrm have a boxed warning?
No. None of the 1 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Tralokinumab-ldrm?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Tralokinumab-ldrm been recalled?
FDA enforcement reports list 1 recall of products of this medicine; the newest started February 10, 2026 (Class II). A recall usually concerns specific lots, not every product.
Who makes Tralokinumab-ldrm?
1 company lists prescription products of Tralokinumab-ldrm in the FDA NDC Directory, including LEO Pharma Inc..

What Tralokinumab-ldrm is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

ADBRY 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. …

— FDA label: Adbry, LEO Pharma Inc., effective December 17, 2025. 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.

The label quoted above has no boxed warning.

Forms and how it is given

Dosage formsInjection, solution
RouteSubcutaneous
Prescription products2 in the FDA NDC Directory
Brand namesAdbry

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.

FDA approval history

  • BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
BLA761180
ADBRY		 Leo Pharma AsDecember 27, 2021 6, latest December 17, 2025
2025: Type 1 - New Molecular Entity · 2025: Labeling · 2024: Efficacy

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. February 10, 2026 · Class II · Ongoing · D-0339-2026

    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.

    Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose Autoinjector, SAMPLE NOT FOR SALE, NDC 50222-350-91; b) 2 x Single dose Autoinjectors, NDC 50222-350-02; Rx only, Manufactured by: LEO Phar — LEO PHARMA INC

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)2589378, 2589384, 2686061, 2686065
SPL set ID of the quoted labeld8020b69-3001-44e2-9b5d-5f93d9aaf6e1
FDA labels (SPL)1
FDA applicationsBLA761180
Active ingredients (FDA)TRALOKINUMAB

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Adbry, LEO Pharma Inc., effective December 17, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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 →

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