ARTICLE | Clinical News

Feraheme ferumoxytol regulatory update

December 6, 2010 8:00 AM UTC

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. ...