Quick answers
- What is Tezepelumab-ekko used for?
- The FDA-approved label (Tezspire, Amgen Inc, October 17, 2025) says: “TEZSPIRE is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated: • for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tezepelumab-ekko 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 Tezepelumab-ekko?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tezepelumab-ekko been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tezepelumab-ekko?
- 1 company lists prescription products of Tezepelumab-ekko in the FDA NDC Directory, including Amgen, Inc.
What Tezepelumab-ekko is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TEZSPIRE is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated: • for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus. …
— FDA label: Tezspire, Amgen Inc, effective October 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.
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.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Tezspire |
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.
- Amgen, Inc2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761224 TEZSPIRE | Astrazeneca Ab | December 17, 2021 | 3, latest October 17, 2025 2025: Efficacy · 2023: Labeling · 2023: Efficacy |
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) — Tezspire, Amgen Inc, effective October 17, 2025; 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 →