Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

AMAG Pharma Submits SNDA To FDA For Ferahame Inj.

RELATED NEWS
Trade AMAG now with 

AMAG Pharmaceuticals, Inc. (AMAG: Quote) Monday said it has submitted a supplemental new drug application, or sNDA, to the Food and Drug Administration, for Feraheme Injection.

The sNDA proposes expansion of indications for the Ferahame, or ferumoxytol, injection for a treatment of iron deficiency anemia in adult patients with IDA who have failed or could not tolerate oral iron treatment.

The sNDA submission includes data from a global phase III program that evaluated the use of ferumoxytol in a broad range of adult IDA patients, all of whom had failed or could not tolerate oral iron treatment. More than 1,400 patients were enrolled in the two phase III clinical trials.

The regulatory approval of Feraheme for a broader IDA patient population would expand the company's market opportunity in the existing U.S. IV iron market, beyond its current CKD indication.

Click here to receive FREE breaking news email alerts for AMAG Pharmaceuticals Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Specialty drugmaker Horizon Pharma plc (HZNP) on Friday managed to redomicile itself as an entity incorporated in Ireland following the completion of its $660 million acquisition of Vidara Therapeutics International plc. The deal will help it avoid paying the high rate of U.S. corporate taxes. The... Stocks showed a lack of direction over the course of the trading day on Friday after failing to sustain an initial upward move. Despite the choppy trading, the Dow once again managed to end the session at a new record closing high. The major averages turned in a mixed performance on the day. President Barack Obama delivered a statement Thursday evening thanking members of Congress for voting to approve legislation granting the U.S. military the authority to train and arm moderate Syrian rebels fighting against the terrorist group known as the Islamic State.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.