Luitpold Pharmaceuticals, Inc. receives complete response letter for Injectafer® from the U.S. FDA

Luitpold Pharmaceuticals, Inc. had submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Injectafer® (ferric carboxymaltose injection)for the treatment of iron deficiency anemia on September 30, 2011.

As part of this submission, Luitpold Pharmaceuticals provided the FDA with safety and efficacy data from two large scale, multi-center, randomized clinical trials. One trial compared Injectafer® to Venofer® in patients with iron deficiency anemia and chronic kidney disease. The second study compared Injectafer® to either oral or IV iron (standard of care therapy) in patients with iron deficiency anemia of various etiologies.

In the Complete Response Letter the FDA noted its decision to withhold approval at this time. The decision was not related to any issues with the Injectafer NDA filing, but with Luitpold’s manufacturing facility in Shirley, N.Y.

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 Pharmaceuticals is working with the FDA to resolve the issues found in the FDA’s recent inspection.

Luitpold believes it has adequately responded to all the clinical questions concerning Injectafer® raised by the FDA during the current review period.

Injectafer®, a novel IV iron replacement therapy was approved by the UK Medicines & Healthcare products Regulatory Agency (MHRA), in 2007 and acting as a Reference country, supported the subsequent approval of Ferinject® (brand name outside of U.S.) throughout the European Union and the Swiss regulatory agency Swissmedic. Ferinject® is currently registered for use in 40 countries worldwide.