FDA approves Uniferon® 200 injectable iron supplement for baby pigs

March 29, 2011

The Food and Drug Administration (FDA) has announced the contract manufacturing site approval of Uniferon® 200 (Iron Dextran Complex Injection, 200mg/mL), which is to be utilized for the prevention and treatment of iron deficiency anemia in baby pigs.

The supply of injectable iron dextran products in the US in recent years has been inconsistent, according to the FDA, resulting in shortages.

As a result, FDA determined that the Uniferon® 200 product was a medically necessary veterinary drug product, and the Agency issued discretionary approval letters to certain properly qualified foreign companies, allowing the foreign companies to temporarily import and distribute Iron Dextran Complex Injection, 200 mg/mL products in the U.S.

"This announcement of the approval of Uniferon should provide an adequate U.S. domestically manufactured supply and therefore effectively end any current shortages," FDA says.

Uniferon® 200 (Iron Dextran Complex Injection, 200 mg/ml) is manufactured by Pharmacosmos, Inc. of Watchung, NJ, and distributed by Ivesco of Iowa Falls, IA.

For more information regarding pricing and availability of Uniferon® 200, contact Ivesco.

About Injectable Iron

Baby pigs are very susceptible to iron deficiency anemia. Therefore, iron deficiency anemia in litters of baby pigs poses a risk to both animal health, welfare, and productivity. An injection of iron shortly after farrowing is an effective and is a globally established "best practices method" utilized to prevent iron deficiency anemia in baby pigs.

About Uniferon 200

Uniferon 200 is a modern and much improved iron hydrogenated dextran, based upon a very low impurity profile formulation, whereby this source of injectable iron for baby pigs has been approved by numerous healthcare authorities for global use.

Pharmacosmos manufactures iron dextran of high quality and unique purity, which is distributed to human and animal drug customers worldwide. Uniferon 200 is the only injectable iron brand for baby pigs approved by healthcare authorities in the EU, in the U.S. and in Asia.

About Pharmacosmos

Pharmacosmos Inc, located in Watchung, NJ as a fully owned subsidiary of Pharmacosmos A/S. is dedicated to the sales of veterinary pharmaceuticals for the treatment and prevention of iron deficiency Anemia, including Uniferon 200.

Headquartered in Holbaek, Denmark, Pharmacosmos A/S is a family-owned, international healthcare company with more than 50 years of innovation and leadership in iron- and carbohydrate-based treatments and solutions for human and animal use.

A research-based company, the Pharmacosmos A/S ongoing R&D program focuses on improving the lives of patients with sub-clinical and full-scale iron deficiency anemia. More than 1 billion people live with iron deficiency anemia and it is the leading cause of death for an estimated 180,000 people world-wide every year. This makes sub-clinical and full-scale iron deficiency anemia one of the largest global health challenges of the current time.

Pharmacosmos A/S has subsidiaries in the US, China, Nordics, Germany, UK and Ireland, and its products are marketed in more than 80 countries around the world. The Pharmacosmos A/S manufacturing facilities located in Denmark have supported global healthcare authority approvals, among others, by the Danish Medicines Agency and the U.S. FDA.