AMAG Pharma signs pact with FDA for Feraheme label

The updated product label, also called a package insert, includes bolded warnings and precautions that describe events that have been reported after Feraheme administration in the post-marketing environment, including life-threatening hypersensitivity reactions and clinically significant hypotension.

AMAG Pharma said that the product also include a new section of the label entitled Adverse Reactions from Post-marketing Spontaneous Reports, and an increase in the observation period following Feraheme administration from 30 to 60 minutes to observe patients for signs and symptoms of hypersensitivity.

The updated Feraheme label does not include a boxed warning. Along with the label changes, AMAG has committed to propose a registry to better understand the frequency and timing of adverse events following Feraheme administration.

AMAG president and CEO Brian Pereira said that they are pleased to have reached resolution with the Agency and have this uncertainty behind us.

"As we roll out the updated Feraheme label to physicians who treat adult chronic kidney disease patients with iron deficiency anemia (IDA), we look forward to devoting our full attention to the commercialisation of Feraheme in this patient population and the advancement of the registrational trials for the broader IDA indication," Pereira said.