FDA approved the original new drug application for VYKOURA on February 3, 2026, sponsored by AVYXA HOLDINGS. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA220406
- Sponsor
- AVYXA HOLDINGS
- Original approval
- Review
- standard review
- Submission class
- Type 5 - New Formulation or New Manufacturer
- Active ingredient
- leucovorin calcium
Browse every approval whose brand starts with V, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| leucovorin calcium EQ 500MG BASE/50ML (EQ 10MG BASE/ML) | SOLUTION | INTRAMUSCULAR, INTRAVENOUS | Prescription |
| leucovorin calcium EQ 50MG BASE/5ML (EQ 10MG BASE/ML) | SOLUTION | INTRAMUSCULAR, INTRAVENOUS | Prescription |
| leucovorin calcium EQ 350MG BASE/35ML (EQ 10MG BASE/ML) | SOLUTION | INTRAMUSCULAR, INTRAVENOUS | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
FDA’s record shows no approved efficacy supplement on this application.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
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