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
Samsung is planning to sell the recalled Galaxy Note 7 devices as refurbished or rental phones where applicable, but not in US. In a statement, the company said, "Regarding the Galaxy Note 7 devices as refurbished phones or rental phones, applicability is dependent upon consultations with regulatory authorities and carriers as well as due consideration of local demand. The markets and release dat Hollywood is spending more than ever to produce movies, with new technology and computer graphics imaging (CGI) bringing superheroes to life. Directors constantly one-up one another with special effects, while actors like Johnny Depp or Tobey Maguire are demanding beaucoup bucks to reprise their... Sluggish sales of video games have forced GameStop to take a decision to close around 150 retail locations. Digital downloads and competition from rivals are said to be the reason for shut down. The company operates around 6600 stores worldwide and has not revealed the list of shops to be closed. According to reports GameStop is planning the closure of up to 3 percent of their shops.
comments powered by Disqus
Follow RTT