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FDA Delays Approval of Amag's Ferumoxytol
Unresolved manufacturing issues have contributed to a delay in the approval of Amag Pharmaceuticals'(AMAG Quote) injectable iron replacement therapy, the company announced Monday night.
Amag said it received a second complete response letter from the Food and Drug Administration, ahead of the agency's expected approval decision date of Dec. 30.
The company is seeking FDA approval for ferumoxytol, now known by its brand name Feraheme, as a treatment for iron-deficiency anemia in patients with chronic kidney disease. ...
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