Quick answers
- What is Pretomanid used for?
- The FDA-approved label (Pretomanid, Viatris Specialty LLC, November 15, 2024) says: “Limited Population: Pretomanid Tablet is indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary tuberculosis (TB) resistant to isoniazid, rifamycins, a fluoroquinolone and a second line injectable antibacterial drug OR adults with pulmonary TB resistant to isoniazid and rifampin, who are treatment-intolerant or nonresponsive to standard therapy. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pretomanid 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 Pretomanid?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pretomanid been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Pretomanid?
- 1 company lists prescription products of Pretomanid in the FDA NDC Directory, including Viatris Specialty LLC.
What Pretomanid is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Limited Population: Pretomanid Tablet is indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary tuberculosis (TB) resistant to isoniazid, rifamycins, a fluoroquinolone and a second line injectable antibacterial drug OR adults with pulmonary TB resistant to isoniazid and rifampin, who are treatment-intolerant or nonresponsive to standard therapy. …
— FDA label: Pretomanid, Viatris Specialty LLC, effective November 15, 2024. 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 forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
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.
- Viatris Specialty LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA212862 PRETOMANID | Mylan Ireland Ltd | August 14, 2019 | 2, latest November 22, 2024 2024: Efficacy · 2022: 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) | 2198370 |
|---|---|
| SPL set ID of the quoted label | f1906fc9-cb3c-4e13-8a4a-da76100c1bf3 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA212862 |
| Active ingredients (FDA) | PRETOMANID |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Pretomanid, Viatris Specialty LLC, effective November 15, 2024; 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 →