Quick answers
- What is Anidulafungin used for?
- The FDA-approved label (Eraxis, Roerig, August 19, 2025) says: “ERAXIS is an echinocandin antifungal indicated for the treatment of the following infections: • Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older) • Esophageal candidiasis in adults Limitations of use • ERAXIS has not been studied in adult and pediatric patients with endocarditis, osteomyelitis, and meningitis due to …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Anidulafungin have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Anidulafungin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Anidulafungin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Anidulafungin?
- 1 company lists prescription products of Anidulafungin in the FDA NDC Directory, including Roerig.
What Anidulafungin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ERAXIS is an echinocandin antifungal indicated for the treatment of the following infections: • Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older) • Esophageal candidiasis in adults Limitations of use • ERAXIS has not been studied in adult and pediatric patients with endocarditis, osteomyelitis, and meningitis due to …
— FDA label: Eraxis, Roerig, effective August 19, 2025. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
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.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Eraxis |
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.
- Roerig3 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021632 ERAXIS | Vicuron Holdings | February 17, 2006 | 15, latest October 5, 2020 2020: Labeling · 2020: Labeling · 2020: 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) | 1804743, 1804746, 1804748, 1804750 |
|---|---|
| SPL set ID of the quoted label | a88d9010-55fb-4a02-baff-042cd27688ea |
| FDA labels (SPL) | 2 |
| FDA applications | NDA021632 |
| Active ingredients (FDA) | ANIDULAFUNGIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Eraxis, Roerig, effective August 19, 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 →