AMAG announces drug label update
AMAG Pharmaceuticals Inc. said it has reached an agreement with the Food and Drug Administration regarding an update to the product label for Feraheme, an anemia drug.
The Lexington-based firm said recently that it would slash 24 percent of its workforce due to declining sales and safety concerns tied to Feraheme, a Globe brief noted.
In a press release this morning, the company said its updated product label included "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."
In a statement, Brian J.G. Pereira, president and chief executive officer of AMAG, said: "We 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 commercialization of Feraheme in this patient population and the advancement of the registrational trials for the broader IDA indication."
AMAG said it has scheduled an audio webcast and conference call today at 8:00 a.m. to discuss the press release.