AMAG Pharmaceuticals, Inc.
FDA Decision on Feraheme NDA Expected Within Next Few Days
Published in Drug Week, September 18th, 2009
AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG) 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...
Want to see the full article?
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Drug Week
Source: Drug Week (2009-09-18)
More Articles from Drug Week
- American Academy of Neurology
Cigarettes, not Swedish snuff linked to increased risk of MS - American Academy of Sleep Medicine
Chemotherapy for breast cancer is associated with disruption of sleep-wake rhythm in women - American Gastroenterological Association
GERD negatively impacts sleep quality, results in considerable economic burden - American Gastroenterological Association
Men experience sexual dysfunction during hepatitis C therapy - Ecole Polytechnique Federale de Lausanne
A new molecule to combat diabetes and obesity - European Society of Cardiology
PROTECT study - More from this issue of Drug Week
NewsRx is Social
Follow us on your favorite social network by clicking on a button below:
Top Medical Newsletters
Awards
Best Health/Healthcare Content, 2012
Best Health/Healthcare Content, 2011
Best e-Business Site, 2010
Best e-Business Site, 2009
Best e-Business Site, 2008
Best e-Business Site, 2007
Best e-Business Site, 2006
Best Healthcare Content, 2005
Best Overall Internet Site, 2005
Best Interactive Site, 2005
Facts & Stats
NewsRx also is available at LexisNexis, Gale, ProQuest, Factiva, Dialog, Thomson Reuters, NewsEdge, and Dow Jones.
- Google 2010 PageRank: #2 Among Top Health News and Media Publications
- Google 2010 PageRank: #2 Among Top Science Publications in Biology/Physiology
- Google 2010 PageRank: #2 Among Top News and Media for the Business of Pharmaceuticals
- Amazon's Alexa 2010 PageRank: #2 News and Media Site for the Pharmaceutical Industry
