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FDA rejects Amag request to expand Feraheme use; wants more data

  • Amag Pharmaceuticals (AMAC) receives the dreaded complete response letter from the FDA over the company's request to expand the use of its Feraheme (ferumoxytol) injection from just chronic kidney disease to include all adult iron deficiency anemia (IDA) patients who have failed or cannot tolerate oral iron treatment.
  • In the CRL, which the FDA uses to tell companies that an application cannot be authorized in its present form, the agency said that Amag has not provided sufficient information for approval. The FDA suggested that Amag carry out further studies.
  • Amag is due to hold a conference call at 7:30 ET to discuss the CRL. (PR)
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