Press release

Venofer® (Iron Sucrose Injection, USP) receives US FDA approval for Paediatric Indication

Wednesday, 26 September 2012, ↓ directly to download

Vifor Pharma, a company of the Galenica group, is pleased to inform that its US partner Luitpold Pharmaceuticals has received US Food and Drug Administration (FDA) approval for use of Venofer® (Iron Sucrose Injection USP) in paediatric patients.

American Regent, Inc., the human health subsidiary of Luitpold Pharmaceuticals, Inc., has announced that Venofer® (Iron Sucrose Injection USP) is now approved for use in paediatric patients. This FDA approval now broadens the approved indications for Venofer® to include administration to children ages 2 years and older for Iron Deficiency Anaemia in all stages of Chronic Kidney Disease (CKD).

Iron Deficiency Anaemia (IDA) is a common co-morbid condition in pre-dialysis CKD and End Stage Renal Disease (ESRD) where the body does not have enough iron to produce a normal supply of red blood cells. The prevalence of ESRD in paediatric patients has grown 32% since 19901. According to the United States Renal Data Systems (USRDS) 2012 Annual Report, the prevalence rate of Paediatric ESRD in the United States reached 86 per 1 million population in 2010, with almost 7,000 paediatric patients on dialysis2.

Vifor Pharma, a company of the Galenica Group, is a world leader in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency. The company also offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world.

Venofer®, the originator iron sucrose, is an intravenous iron therapy developed by Vifor Pharma. Venofer® is authorized worldwide in more than 80 countries for the treatment of iron deficiency and iron deficiency anaemia where there is a clinical need for a rapid iron supply or when oral iron is ineffective, not tolerated or patient non-compliance is an issue. To date over 5,000 patients have been documented in clinical studies. In many countries, intravenous (i.v.) iron therapies are primarily used to treat dialysis patients, and with an efficacy and safety profile distinct from iron sucrose similar therapies, Venofer® has become the most widely used i.v. iron product in haemodialysis patients.

Iron Deficiency Anemia (IDA) is defined as a state in which iron stores are inadequate for normal blood formation, as the iron requirements exceed the supply. Iron deficiency anaemia results from low or depleted stores of iron. In severe cases red cells in a patient with IDA are both microcytic (small) and hypochromic (pale), and values for mean corpuscular volume (MCV) and mean corpuscular Hb concentration (MCHC) are characteristically changed. According to the World Health Organization (WHO) it is estimated that about 700 million people have iron deficiency anaemia (IDA). [Source: World Health Organization. Preventing and controlling Iron Deficiency Anaemia through primary health care. Available at:]

Luitpold Pharmaceuticals, Inc., a Daiichi Sankyo Group Company, headquartered in Shirley, NY, US, manufactures over 80 pharmaceutical products including Venofer® (iron sucrose injection, USP), which are distributed through its human health subsidiary, American Regent, Inc.
For more information on Luitpold or any of its divisions and products, please visit:

1. Warady, BA., Chadha, V. Chronic kidney disease in children: the global perspective. Pediatr Nephrol. 2007 December; 22(12):1999-2009.
2. USRDS 2012 Annual Data Report, National Institute of Health.


Beatrix Benz

Head of Global Communications & Public Affairs

Vifor Pharma Ltd.

Global Communications
Flughofstrasse 61
P.O. Box
CH-8152 Glattbrugg

+41 58 851 80 00
+41 58 851 80 01

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