Jan 22 Amag Pharmaceuticals Inc said the U.S. Food and Drug Administration rejected its application for a wider use of its iron deficiency drug, sending its shares down 18 percent in premarket trade.
The regulator said the company had not provided enough information for the FDA to label the drug as safe for use in patients with adult iron deficiency anemia (IDA) who have failed or cannot tolerate oral iron treatment.
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.
The drug, Feraheme, is already approved to treat iron deficiency anemia in adult chronic kidney disease patients.
Amag's shares were trading at $18 before the bell, after closing at $21.86 on the Nasdaq on Monday. (Reporting By Vrinda Manocha in Bangalore; Editing by Saumyadeb Chakrabarty)