Ferric Carboxymaltose

For heart failure and New York Heart Association class II/III. ANDA 217076, held by Mylan. Ferric Carboxymaltose.

As of Nov 15, 2026, ANDA 217076 (Ferric Carboxymaltose), held by Mylan, was first approved by FDA on Jun 25, 2026, with 0 approved supplements and 0 published complete response letters.

First approved: Jun 25, 2026
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Ferric carboxymaltose injection is indicated for the treatment of:

iron deficiency anemia (IDA) in: o adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. o adult patients who have non-dialysis dependent chronic kidney disease.
iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Jun 25, 2026	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Ferric Carboxymaltose1GM IRON/20ML (50MG IRON/ML) · solution;intravenous	Ferric Carboxymaltose	Rx

Identifiers

Application: ANDA 217076
Drugs@FDA: Overview at FDA
Company: Mylan

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