FDA approves iron dextran formulation to avert shortage
The formulation, called Uniferon by Pharmacosmos of Watchung, N.J. (distributed by IVESCO of Iowa Falls, Iowa), is labeled for the prevention and treatment of iron deficiency anemia in baby pigs.
"In recent years there has been an inconsistent supply of injectable iron dextran products in the United States resulting in shortages," the agency says. "FDA determined the product was a medically necessary drug and issued letters of no objection to certain approved companies allowing them to temporarily import and distribute an injectable 200 mg/ml iron dextran product into the United States."
The approval should end any current shortages of injectable iron dextran, the agency adds.