AMAG seeks FDA sNDA approval for Feraheme Injection

Published on December 25, 2012 at 12:04 PM · No Comments

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that it has submitted a supplemental new drug application (sNDA) to the United States Food and Drug Administration (FDA) for Feraheme® (ferumoxytol) Injection for Intravenous (IV) use. The sNDA requests FDA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to all adult patients with IDA who have failed or could not tolerate oral iron treatment. The application includes data from two well-controlled phase III clinical trials of more than 1,400 patients.

“We believe that Feraheme, if approved for this indication, could provide a new treatment option for patients suffering from iron deficiency anemia who cannot tolerate or do not respond to oral iron therapy.”

"This submission marks an important corporate milestone and represents the culmination of several years of work here at AMAG. The regulatory approval of Feraheme for a broader IDA patient population would expand our market opportunity in the existing U.S. IV iron market, beyond our current CKD indication," said William Heiden, president and chief executive officer of AMAG. "We believe that Feraheme, if approved for this indication, could provide a new treatment option for patients suffering from iron deficiency anemia who cannot tolerate or do not respond to oral iron therapy."

Read in | English | Español | Français | Deutsch | Português | Italiano | 日本語 | 한국어 | 简体中文 | 繁體中文 | Nederlands | Русский | Svenska | Polski
Comments
The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News-Medical.Net.
Post a new comment
Post