FDA · United States
sodium ferric gluconate complex — FDA regulatory status
sodium ferric gluconate complex (FERRLECIT) 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
- FERRLECIT
- Mechanism
- Supplement
- Structured fields
- 5
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: 11 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 |
|---|---|---|---|
| Ferric Citrate 1 GM Oral Tablet [AURYXIA] | Phase 3 | Akebia Europe | NCT05085275 |
| Ferric Carboxymaltose Injection | Phase 1 | First People's Hospital | NCT06895993 |
| Ferric Citrate 1 gram Oral Tablet | Approved | Akebia Europe | NCT04922645 |
| Ferric carboxymaltose | Approved | United Therapeutics Europe | NCT01701310 |
| Ferric carboxymaltose | Approved | Takeda | NCT03871699 |
| Ferric derisomaltose | Approved | Chinese Academy of | NCT05991128 |
| Ferric derisomaltose | Approved | Chinese Academy of | NCT05971732 |
| ferric carboxymaltose | Approved | Fresenius Medical Care | NCT02937454 |
| Ferric carboxymaltose | Unknown | United Therapeutics Europe | NCT02308449 |
| Nutra 1-0602 | Unknown | Harmony Biosciences Holdings | NCT06605768 |
| Nutra 2-1216 | Unknown | Harmony Biosciences Holdings | NCT07520019 |
Related hubs
FAQ
What is the FDA approval status of sodium ferric gluconate complex?
sodium ferric gluconate complex 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 sodium ferric gluconate complex 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 sodium ferric gluconate complex?
This spoke lists 11 published programs associated with sodium ferric gluconate complex in our pipeline index.