AMAG Expects FDA Decision for Feraheme within Next Few Days

Monday, 29 June 2009 15:40

LEXINGTON, Mass.--AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG - News) today announced that it has not received an action letter from the U.S. Food and Drug Administration (FDA) for Feraheme™ (ferumoxytol) Injection for the treatment of iron deficiency anemia in adult chronic kidney disease patients. The Prescription Drug User Fee Act (PDUFA) action date was today, June 29, 2009. The FDA informed the Company that the Agency would not take action today, but expects to issue an action letter within the next few days. The FDA has not requested any additional information from the Company, and it is the Company’s understanding that there are no outstanding issues regarding the Feraheme New Drug Application.

Conference Call and Webcast Access

AMAG Pharmaceuticals, Inc. will host a webcast and conference call tomorrow at 8:30 a.m. ET to discuss the announcement.

To access the conference call via telephone, please dial (866) 501-5516 from the U.S. or (702) 495-1202 for international callers. A telephone replay will be available from approximately 11:30 a.m. ET on June 30, 2009 through midnight July 2, 2009. To access a replay of the conference call, dial (800) 642-1687 from the U.S. or (706) 645-9291 for international access. The passcode for the live call and the replay is 17087311.

An audio webcast of the call will be available through the Investors section of the Company’s website at www.amagpharma.com. A replay of the webcast will also be available from approximately 10:30 a.m. ET on June 30, 2009, through midnight July 6, 2009.

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