AMAG Pharmaceuticals has received a notice of three-month extension from the US Food and Drug Administration (FDA) for a supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection to be used for intravenous (IV) therapy.
The sNDA seeks to expand the indication for Feraheme beyond the existing indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to include all adult patients with IDA who have failed or cannot tolerate oral iron treatment.
According to the company, the new prescription drug user fee act (PDUFA) action date has been extended to 21 January 2014.
AMAG Pharmaceuticals president and CEO William Heiden said over the past few weeks, the company has had a productive dialogue with the FDA and has provided them with additional information related to the review of the sNDA for Feraheme.
"This week, the FDA informed us that they need additional time to review the submitted information," Heiden said.
"We will work with the FDA over the next three months to answer any questions that they may have, and continue to believe that approval of the Feraheme sNDA would provide physicians with an important treatment option for patients with IDA, who have failed or could not tolerate oral iron."
