ARTICLE | Clinical News

Feraheme ferumoxytol regulatory update

January 13, 2014 8:00 AM UTC

AMAG disclosed in an SEC filing that FDA has not yet discussed proposed labeling or postmarketing requirements with AMAG for Feraheme ferumoxytol, despite the upcoming Jan. 21 PDUFA date for an sNDA for the anemia drug. AMAG is seeking to expand Feraheme's label to include the treatment of all adult patients with iron deficiency anemia who have failed or could not tolerate oral iron treatment. The IV iron replacement therapy is approved to treat iron deficiency anemia in adult patients with chronic kidney disease (CKD). According to AMAG, FDA said the sNDA is still under active review. Last October, FDA extended the PDUFA date for the application by 3 months to Jan. 21(see BioCentury, Oct. 21, 2013). In September, AMAG disclosed in an 8-K that it received notification from FDA that the agency identified undisclosed "deficiencies" in the Feraheme sNDA that prevented the agency from discussing potential labeling or postmarketing requirements by its target date of Sept. 23, 2013 (see BioCentury, Sept. 30, 2013). ...