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Injectafer

Generic name: ferric carboxymaltose
Treatment for: Iron Deficiency Anemia

Update: Injectafer (ferric carboxymaltose injection) Now FDA Approved - July 25, 2013

Injectafer Receives FDA Non-Approvable Letter

Luitpold Pharmaceutical’s Injectafer (ferric carboxymaltose injection) Receives Non-Approvable Letter From FDA

SHIRLEY, NY, March 12, 2008 – Luitpold Pharmaceuticals, Inc. reported today that the U.S. Food and Drug Administration (FDA) has issued a non-approvable letter for its new drug application (NDA) for Injectafer (ferric carboxymaltose injection) (Internal name VIT-45), an intravenous iron injection, for the treatment of iron deficiency anemia in women due to postpartum (PP) or heavy uterine bleeding (HUB).

In the non-approvable letter, the FDA requested safety data from additional clinical studies to address concerns over the safety of Injectafer in this population, specifically the mortality signal discussed at the February 1, 2008 meeting of the Drug Safety and Risk Management Advisory Committee.

"While we are disappointed about this latest decision, we are committed to the further development of Injectafer and are working on new studies in support of our application and to address the FDA's concerns," said Mary Jane Helenek, President & CEO.

In February 2008, the Drug Safety and Risk Management Advisory Committee of the FDA voted that that the available safety and efficacy data supported a favorable risk / benefit profile of Injectafer (ferric carboxymaltose injection) for the treatment of iron deficiency anemia patients in women with heavy uterine or post-partum bleeding, but recommended that the usage be restricted to patients who have had an unsatisfactory response to oral iron or are intolerant to oral iron.

The development program for Injectafaer represents the largest prospectively enrolled program of any intravenous iron product ever submitted to the Agency for approval. Data were derived from 12 multicenter trials involving more than 3,000 subjects with iron deficiency anemia secondary to a variety of conditions besides HUB and PP, including non-dialysis and hemodialysis dependent chronic kidney disease patients and patients with inflammatory bowel disease.

Iron deficiency anemia represents a significant health issue in women. More than half of the 4 million women who give birth each year develop iron deficiency and approximately 1 million of these women progress to iron deficiency anemia. In addition, as many as one in five women will suffer from heavy uterine bleeding, defined as excessive or prolonged blood loss.

Once approved, Injectafer will be marketed in the U.S. by American Regent, Inc., a subsidiary of Luitpold Pharmaceuticals. Injectafer was approved in 18 countries in Europe in June 2007 and in Switzerland in November 2007.

About Luitpold Pharmaceuticals, Inc.

Luitpold Pharmaceuticals, Inc., headquartered in Shirley, NY, manufactures and distributes over 65 pharmaceutical products including Venofer, the leading IV iron therapy in the U.S. through its human health subsidiary, American Regent. Luitpold, a wholly owned subsidiary of Daiichi-Sankyo Pharma, Inc., also markets dental bone regeneration products and veterinary pharmaceuticals through its Osteohealth and Animal Health divisions.

Source: Luitpold Pharmaceuticals, Inc.

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Contact: Walter Tozzi

Director of Marketing and Professional Services

American Regent, Inc.

631-924-4000

Posted: March 2008

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