Amag Complete Response Letter Cites Preapproval Inspection

The FDA issued a second complete response letter for Amag Pharmaceuticals’ anemia drug ferumoxytol, citing deficiencies investigators observed during a preapproval inspection of the company’s manufacturing facility.

Ferumoxytol is designed to treat iron-deficiency anemia in patients with chronic kidney disease. The company submitted an NDA in December 2007 and received a complete response letter from the FDA last October. The company responded with a Class I resubmission and has received a second complete response letter.

The FDA is asking for data to clarify a specific question regarding chemistry, manufacturing and controls, which the company will not describe further. The agency also is asking Amag to resolve issues discovered during the inspection, as well as labeling concerns.
Drug GMP Report