FDA rejects wider use of Amag anemia drug; shares slide
Amag Pharmaceuticals Inc said the U.S. Food and Drug Administration rejected its application for wider use of its iron deficiency drug due to safety concerns and asked for more trial data, sending its shares down as much as 15 percent. In a "complete response letter" to Amag, the FDA suggested that the company generate additional safety data for the wider patient population and evaluate the dosing or administration of the drug, Feraheme. "The FDA did propose that the company conduct additional trials," Amag Chief Executive William Heiden told Reuters. "We do have existing safety data from our two large late-stage trials … certainly we would look to that data to support the safety profile of Feraheme." The FDA asked Amag to provide additional safety data related to serious hypersensitivity, cardiovascular events and deaths.
