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

Editors Pick
LinkedIn Corp., the world's largest online professional network, said Thursday after the markets closed that it swung to a second quarter loss, hurt by higher costs and expenses even as revenue surged 47%. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations as did its quarterly revenue. Kraton Performance Polymers, Inc. (KRA), Wednesday reported second-quarter net income of $11.1 million or $0.33 per share, up from $3.8 million or $0.12 per share last year. Adjusted earnings improved to $0.46 per share from $0.15 per share last year. Revenues for the quarter dropped to $323.8... Organic grocer Whole Foods Market, Inc. said Wednesday after the markets closed that its third quarter profit rose 6.3% from last year, as same-store sales increased 3.9%. The company's quarterly earnings per share also came in above analysts' expectations, but its quarterly sales fell shy of analyst' forecast.
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.