NDA 220436, held by Avyxa Holdings. Fosaprepitant Dimeglumine.
As of Nov 13, 2026, NDA 220436 (Navitrux), held by Avyxa Holdings, was first approved by FDA on Jun 24, 2026, with 0 approved supplements and 0 published complete response letters.
NAVITRUX, in combination with other antiemetic agents, is indicated in adults and pediatric patients 6 months of age and older for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Limitations of Use NAVITRUX has not been studied for the treatment of established nausea and vomiting. NAVITRUX is a substance P/neurokinin-1 (NK 1 ) receptor antagonist,
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 24, 2026 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| NavitruxEQ 150MG BASE/VIAL · powder;intravenous | Fosaprepitant Dimeglumine | RxReference drug |
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
