FDA · United States
ferric derisomaltose — FDA regulatory status
ferric derisomaltose (MONOFER) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- MONOFER
- Originator
- A.Menarini Australia Pty Limited
- Mechanism
- Supplement
- Structured fields
- 6
Sponsor / originator context: A.Menarini Australia Pty Limited. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Supplement. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 5 published clinical programs and 0 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| Monofer | Phase 3 | Cosmo Pharmaceuticals | NCT01222884 |
| P-Monofer-CHF-02 | Phase 3 | Anaxis Pharma | 2024-519059-28-00 |
| iron isomaltoside(Monofer®) | Phase 3 | Hospital Authority | NCT03565354 |
| Ferric derisomaltose | Approved | Chinese Academy of | NCT05971732 |
| Ferric derisomaltose | Approved | Chinese Academy of | NCT05991128 |
Related hubs
FAQ
What is the FDA approval status of ferric derisomaltose?
ferric derisomaltose currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get ferric derisomaltose regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to ferric derisomaltose?
This spoke lists 5 published programs associated with ferric derisomaltose in our pipeline index.