FDA rejects wider use of Amag's anemia drug

January 22, 2014 1:11 PM

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FDA rejects wider use of Amag's anemia drug

(Reuters) - 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.

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