Quick answers
- What is Teplizumab-mzwv used for?
- The FDA-approved label (Tzield, Provention Bio, Inc., August 14, 2026) says: “TZIELD is indicated to […]: Delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients 1 year of age and older with Stage 2 T1D. Delay the decline in endogenous insulin production in pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 T1D. This indication is approved under accelerated approval based on evidence of reduced C-peptide decline […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Teplizumab-mzwv have a boxed warning?
- Yes. The FDA label for Tzield has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Teplizumab-mzwv?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Teplizumab-mzwv been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Teplizumab-mzwv?
- 1 company lists prescription products of Teplizumab-mzwv in the FDA NDC Directory, including Provention Bio, Inc..
What Teplizumab-mzwv is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TZIELD is indicated to […]: Delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients 1 year of age and older with Stage 2 T1D. Delay the decline in endogenous insulin production in pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 T1D. This indication is approved under accelerated approval based on evidence of reduced C-peptide decline […]. …
— FDA label: Tzield, Provention Bio, Inc., effective August 14, 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. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Tzield |
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.
- Provention Bio, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761183 TZIELD | Provention Bio Inc | November 17, 2022 | 3, latest June 12, 2026 2026: Manufacturing (CMC) · 2026: Efficacy · 2026: 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
| RxCUI (RxNorm) | 2621885, 2621891 |
|---|---|
| SPL set ID of the quoted label | e8a39a5f-139c-4510-9777-71cbb00138fa |
| FDA labels (SPL) | 1 |
| FDA applications | BLA761183 |
| Active ingredients (FDA) | TEPLIZUMAB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tzield, Provention Bio, Inc., effective August 14, 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 →