AMAG receives FDA response letter for ferumoxytol

LEXINGTON, Mass—AMAG Pharmaceuticals said Oct. 20 that it has received a complete response letter from the U.S. Food and Drug Administration about its marketing application for the iron drug ferumoxytol.

AMAG said it believes it can address all of the issues the FDA raised in its letter in a “timely manner without conducting any additional clinical trials prior to approval.”

Ferumoxytol is being developed for use as an intravenous iron replacement therapeutic to treat iron deficiency anemia in CKD patients. In Dec. 2007, AMAG submitted a New Drug Application for the marketing approval of ferumoxytol.

No details of the FDA letter were released, but AMAG said it is still preparing for the commercial launch of ferumoxytol in the first quarter of 2009.

"We believe that we will be able to provide the information requested by the FDA in an expeditious manner," Brian J.G. Pereira, president and CEO, AMAG Pharmaceuticals, said in a statement. "We will continue to work closely with the FDA and look forward to bringing ferumoxytol to market, which if approved, could provide a new treatment option for chronic kidney disease patients with iron deficiency anemia."