NDA 216686, held by Steriscience. Fosaprepitant Dimeglumine.
As of Nov 13, 2026, NDA 216686 (Focinvez), held by Steriscience, was first approved by FDA on Aug 22, 2023, with 2 approved supplements and 1 published complete response letter.
FOCINVEZ, 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 FOCINVEZ has not been studied for the treatment of established nausea and vomiting. FOCINVEZ is a substance P/neurokinin-1 (NK 1 ) receptor antagonist,
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 22, 2023 | Original applicationNew dosage form · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Oct 19, 2022 | FosaprepitantProduct Quality/Facility Inspections | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| FocinvezEQ 150MG BASE/50ML (EQ 3MG BASE/ML) · solution;intravenous | Fosaprepitant Dimeglumine | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 30, 2026 | Supplement 4Labeling · Standard review | Approved | |
| May 29, 2025 | Supplement 2Labeling · Standard review | Approved | |
| Aug 22, 2023 | Original applicationNew dosage form · Standard 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
