AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), today announced that the company has reached agreement with the U.S. Food and Drug Administration (FDA) regarding an update to the product label for Feraheme® (ferumoxytol) Injection for intravenous (IV) use. The updated product label, also called a package insert, includes, among other things:
“We are pleased to have reached resolution with the Agency and have this uncertainty behind us”
- 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,
- 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.
"We are pleased to have reached resolution with the Agency and have this uncertainty behind us," said Brian J.G. Pereira, M.D., president and chief executive officer of AMAG. "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 commercialization of Feraheme in this patient population and the advancement of the registrational trials for the broader IDA indication."
Source: AMAG Pharmaceuticals, Inc.