AMAG dives on FDA notice of deficiencies with Feraheme sNDA
This article was originally published in Scrip
Executive Summary
Shares of AMAG took a 16% dive on 25 September after the company disclosed the US FDA had identified deficiencies that preclude discussion of labeling and postmarketing requirements and commitments for the supplemental new drug application (sNDA) for Feraheme (ferumoxytol) for broader use in treating iron deficiency anemia (IDA) in adults with chronic kidney disease (CKD) who have failed or could not use oral iron.