11/30/2010 7:53:31 AM
LEXINGTON, Mass., Nov 29, 2010 (BUSINESS WIRE) -- AMAG Pharmaceuticals, Inc. /quotes/comstock/15*!amag/quotes/nls/amag (AMAG 15.94, +0.03, +0.19%) , today announced that the company has reached agreement with the U.S. Food and Drug Administration (FDA) regarding an update to the product label for Feraheme(R) (ferumoxytol) Injection for intravenous (IV) use. The updated product label, also called a package insert, includes, among other things:
Bolded warnings and precautions that describe events that have been reported after Feraheme administration in the post-marketing environment, including life-threatening hypersensitivity reactions and clinically significant hypotension, A new section of the label entitled Adverse Reactions from Post-marketing Spontaneous Reports, and An increase in the observation period following Feraheme administration from 30 to 60 minutes to observe patients for signs and symptoms of hypersensitivity.
The updated Feraheme label does not include a boxed warning. Along with the label changes, AMAG has committed to propose a registry to better understand the frequency and timing of adverse events following Feraheme administration.
"We are pleased to have reached resolution with the Agency and have this uncertainty behind us," said Brian J.G. Pereira, M.D., president and chief executive officer of AMAG. "As we roll out the updated Feraheme label to physicians who treat adult chronic kidney disease patients with iron deficiency anemia (IDA), we look forward to devoting our full attention to the commercialization of Feraheme in this patient population and the advancement of the registrational trials for the broader IDA indication."
Conference Call and Webcast Access
AMAG Pharmaceuticals, Inc. will host an audio webcast and conference call today at 8:00 a.m. ET to discuss this press release. 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 November 29, 2010 through midnight on December 1, 2010. To access a replay of the conference call, dial (800) 642-1687 from the United States or (706) 645-9291 for international access. The passcode for the live call and the replay is 27619200.
The call will be webcast and accessible through the Investors section of the company's website at www.amagpharma.com. The webcast replay will be available from approximately 11:00 a.m. ET on November 29, 2010 through midnight on December 29, 2010.
About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia. AMAG manufactures and sells Feraheme(R) (ferumoxytol) Injection for intravenous (IV) use. For additional company or product information, please visit www.amagpharma.com or http://feraheme.com.
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