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FDA Rebuffs Injectafer for Iron Deficiency Anemia
During a recent inspection, issues in the manufacturing facility were noted by FDA inspectors. This is the same facility that is to be used to manufacture Injectafer for the U.S. market. Luitpold is working with the FDA to resolve the problems.
As part of the NDA submission for Injectafer, Luitpold provided the FDA with safety and efficacy data from two randomized clinical trials. One study compared Injectafer with Venofer (iron sucrose injection, USP) in patients with iron deficiency anemia and chronic kidney disease. The second study compared Injectafer with either oral or IV iron (standard of care therapy) in patients with iron deficiency anemia from various causes.
Injectafer was approved by the U.K. Medicines & Healthcare Products Regulatory Agency in 2007. The product is currently registered for use in 40 countries worldwide.
For more information, visit the Luitpold Web site.