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)
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