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Trials & Filings

AMAG PDUFA SNDA Date Delayed

Agency needs time to review IV treatment for CKD

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The FDA has extended the review period of AMAG Pharmaceuticals‘ sNDA for Feraheme (ferumoxytol) injection for intravenous (IV) use. The sNDA seeks to expand the indication for Feraheme beyond the current indication for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD) to include all adult patients with IDA who have failed or cannot tolerate oral iron treatment.

The new prescription drug user fee act (PDUFA) action date has been set for January 21, 2014.

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