Feraheme ferumoxytol regulatory update

AMAG said FDA agreed to an updated label for Feraheme ferumoxytol to treat iron deficiency anemia in patients with chronic kidney disease (CKD) that does not include a black box warning. FDA will require the company to include bolded warnings and precautions that describe reported adverse events, including life-threatening hypersensitivity reactions and clinically significant hypotension, a section for adverse reactions from post-marketing spontaneous reports and an increase in the observation period to 60 from 30 minutes following administration of the drug. The company also committed to propose a registry to better understand the frequency and timing of adverse events following Feraheme administration. ...