AMAG Pharmaceuticals, Inc., of Lexington, Mass., has received a Complete Response letter from the FDA regarding ferumoxytol for the treatment of iron deficiency anemia (IDA) in CKD patients.
Before approval can be granted, the agency indicates the need for additional data to clarify a specific chemistry, manufacturing, and controls question; resolution of deficiencies observed during the pre-approval inspection of the company’s manufacturing facility; and finalization of labeling discussions.
Ferumoxytol is being developed for use as an IV iron-replacement therapeutic agent for the treatment of IDA and as a diagnostic agent for vascular-enhanced MRI to assess peripheral arterial disease.
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