Lowers the risk of relapse. NDA 215500, held by Uswm. Eflornithine Hydrochloride.
As of Nov 14, 2026, NDA 215500 (Iwilfin), held by Uswm, was first approved by FDA on Dec 13, 2023, with 1 approved supplement and 0 published complete response letters.
IWILFIN (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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 13, 2023 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| IwilfinEQ 192MG BASE · tablet;oral | Eflornithine Hydrochloride | RxReference drug |
| Nov 26, 2024 | Supplement 1Labeling · Standard review | Approved | |
| Dec 13, 2023 | Original applicationNew formulation or manufacturer · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
