Ferric Carboxymaltose · Regulatory approval

FDA approval: Ferric Carboxymaltose

U.S. Food and Drug Administration · June 25, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA approved a generic ferric carboxymaltose intravenous solution (1 g iron per 20 mL vial, 50 mg/mL) via abbreviated new drug application on 25 June 2026. This is a regulatory action granting market authorization; the record does not contain clinical trial data, efficacy results, or comparative safety information.

What was studied

Regulatory approval. Intervention: Ferric carboxymaltose, 1 g iron per 20 mL intravenous solution (50 mg iron/mL).

Key findings

ANDA217076 approved for ferric carboxymaltose solution, intravenous formulation, 1 g iron per 20 mL (50 mg/mL) Approval date: 25 June 2026 Sponsor: Mylan

Safety

This regulatory record does not contain clinical trial results, efficacy data, or safety outcomes. No information on indication, dosing schedule, contraindications, or adverse event rates is provided.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

FDA approval of a generic ferric carboxymaltose formulation; regulatory action confirming bioequivalence or abbreviated pathway clearance, not a clinical efficacy trial.

Study design

As stated by the source record.

InterventionFerric carboxymaltose, 1 g iron per 20 mL intravenous solution (50 mg iron/mL)

Reported figures

Quoted from the source exactly as published.

Formulation strength1 GM IRON/20ML (50MG IRON/ML)

Route of administrationINTRAVENOUS

Approval date2026-06-25

Caveats

This regulatory record does not contain clinical trial results, efficacy data, or safety outcomes.
Approval via ANDA pathway indicates bioequivalence to a reference product, but comparative clinical data are not reported here.
Study design, sample size, patient population, and outcome measures are not disclosed in this record.
No information on indication, dosing schedule, contraindications, or adverse event rates is provided.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

Regulatory record; no clinical trial design reported.

Directness

insufficient

Approval record does not report clinical outcomes or comparative data.

Consistency

insufficient

Single regulatory action; no comparative or replication data provided.

Risk of bias

insufficient

Not a clinical study; regulatory assessment methodology not detailed.

Sample adequacy

insufficient

No sample size or study population reported in approval record.

Source abstract

Drugs@FDA record for application ANDA217076. This is a regulatory action record, not a clinical study. Brand name: FERRIC CARBOXYMALTOSE. Active ingredient: FERRIC CARBOXYMALTOSE. Sponsor: MYLAN. Submission type: ORIG (original application). Approval status date: 2026-06-25. Products: FERRIC CARBOXYMALTOSE, SOLUTION, INTRAVENOUS, FERRIC CARBOXYMALTOSE 1GM IRON/20ML (50MG IRON/ML).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Ferric CarboxymaltoseMylan