Deferoxamine Mesylate

Treats acute iron intoxication. ANDA 78718, held by Fresenius Kabi USA. Deferoxamine Mesylate.

As of Nov 15, 2026, ANDA 78718 (Deferoxamine Mesylate), held by Fresenius Kabi USA, was first approved by FDA on Sep 15, 2009, with 4 approved supplements and 0 published complete response letters.

First approved: Sep 15, 2009
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Deferoxamine Mesylate for Injection is an iron-chelating agent indicated:

As an adjunct to standard measures for the treatment of acute iron intoxication.
For the treatment of transfusional iron overload in patients with chronic anemia. Limitations of Use Deferoxamine Mesylate for Injection is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder). 1.1 Acute Iron Intoxication Deferoxamine Mesylate for Injection is indicated as an adjunct to standard measures for the treatment of acute iron intoxication. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Sep 15, 2009	Original application	Approved	None posted

Products

2 strengths and forms


Deferoxamine Mesylate500MG/VIAL · injectable;injection	Deferoxamine Mesylate	Rx
Deferoxamine Mesylate2GM/VIAL · injectable;injection	Deferoxamine Mesylate	Rx

All 5 submissions, including labeling and manufacturing supplements


Nov 28, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Jul 18, 2012	Supplement 6Labeling · Standard review	Approved	None posted
Jun 20, 2012	Supplement 5Labeling · Standard review	Approved	None posted
May 27, 2011	Supplement 3Labeling	Approved	None posted
Sep 15, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78718
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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