Prescription medicine
Eflornithine Brand names: Iwilfin; first approved as Ornidyl
Eflornithine (Iwilfin) is a prescription medicine with an FDA approval on record since 1990. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the eflornithine FDA label on DailyMed (effective March 26, 2026, USWM, LLC); the NDA 19879 record on Drugs@FDA; every eflornithine label on DailyMed.
Highlights of the record
FDA label of March 26, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageIWILFIN (eflornithine) is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.
Forms and strengths
- 250 mg
Tablet.
On the market
- Earliest approval on file
- November 28, 1990 Ornidyl, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 12, 2036 Iwilfin tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 41 through July 30, 2026
What is eflornithine used for?
From the label: indications and usageIWILFIN (eflornithine) is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. IWILFIN is an ornithine decarboxylase inhibitor indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.
FDA pharmacologic class: Antiprotozoal and Decarboxylase Inhibitor.
Source: FDA drug label (iwilfin), USWM, LLC, effective March 26, 2026 (SPL set 6716d8cc-66e6-4cee-935c-ccb85ed984f5), via openFDA; the full label on DailyMed
Is there a generic for eflornithine (Iwilfin)?
No generic eflornithine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 1 patent for Iwilfin tablets, the last expiring on February 12, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1990 earliest approval on file
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the eflornithine label say about other medicines?
The eflornithine label names no other medicine on this site. The labels of 1 other medicine name eflornithine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Source: FDA drug label (iwilfin), USWM, LLC, effective March 26, 2026 (SPL set 6716d8cc-66e6-4cee-935c-ccb85ed984f5), via openFDA; the full label on DailyMed
What do FAERS reports show for eflornithine?
The FDA Adverse Event Reporting System holds 41 reports that list eflornithine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 13 are coded as a death and 5 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other antiprotozoals
- the pharmacologic class, with prices and generics
- Eflornithine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other