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, 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