WALTHAM, Mass., Oct. 16, 2013 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) today announced that the U.S. Food and Drug Administration (FDA) has extended its review of a supplemental new drug application (sNDA) for Feraheme® (ferumoxytol) injection for intravenous (IV) use. The sNDA seeks to expand the indication for Feraheme beyond the current indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to include all adult patients with IDA who have failed or cannot tolerate oral iron treatment. The new prescription drug user fee act (PDUFA) action date has been set for January 21, 2014.
"Over the past few weeks, we have had a productive dialogue with the FDA and have provided them with additional information related to the review of the sNDA for Feraheme. This week, the FDA informed us that they need additional time to review the submitted information," said William Heiden, president and chief executive officer of AMAG Pharmaceuticals. "We will work with the FDA over the next three months to answer any questions that they may have, and continue to believe that approval of the Feraheme sNDA would provide physicians with an important treatment option for patients with IDA, who have failed or could not tolerate oral iron."
Conference Call InformationAMAG will hold a conference call on October 17, 2013 at 8:00 a.m., during which management will discuss the PDUFA date extension and a business update. To access the conference call via telephone, please dial (877) 412-6083 from the United States or (702) 495-1202 for international access. A telephone replay will be available from approximately 11:00 a.m. ET on October 17, 2013 through midnight on October 23, 2013. To access a replay of the conference call, dial (855) 859-2056 from the United States or (404) 537-3406 for international access. The pass code for the live call and the replay is 88092945.