logo
Share SHARE
FONT-SIZE Plus   Neg

AMAG Pharma Submits SNDA To FDA For Ferahame Inj.

AMAG Pharmaceuticals, Inc. (AMAG) 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Bank of Nova Scotia or otherwise known as Scotiabank, Friday reported lower net profit for the third quarter, in the absence of a year-ago gain. Earnings per share, however, came in line with the Street view. Further, the company said it raised its quarterly dividend by 2 cents. Non-traditional discount and variety stores operator Big Lots Inc. (BIG) Friday reported a decline in net profit for the second quarter, while net sales grew 1.2 percent from the prior year. Comparable sales for the quarter increased 2.8 percent. Google has rejected the European Union's charges that it abused its market power and the demanded that it change the way it ranks online comparison shopping services in its search results, setting up a potentially long legal battle with the EU regulator empowered to levy billions of euros in fines
comments powered by Disqus
RELATED NEWS
Trade AMAG now with 
Follow RTT