FDA rejects wider use of anemia drug

By Reuters Staff

(Reuters) - Amag Pharmaceuticals Inc said the U.S. Food and Drug Administration rejected its supplemental new drug application for a wider use of its iron deficiency drug, ferumoxytol injection (Feraheme).

The drug is already approved to treat iron deficiency anemia in adult chronic kidney disease patients.

The FDA said the company had not provided enough information for the agency 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 company said it is assessing the content and recommendations of the letter and plans further discussions with the FDA.

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