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news.AMAG Pharmaceuticals has received a notice of non-compliance (NON) from Health Canada regarding its new drug submission (NDS) for Feraheme (ferumoxytol) injection for intravenous (IV) use to treat iron deficiency anemia in adult chronic kidney disease patients.
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The NON outlined Health Canada’s concerns, which are focused mainly on chemistry, manufacturing, and control (CMC) and preclinical toxicology issues.
Health Canada has requested additional information on polyglucose sorbitol carboxymethylether (PSC), a material used in the manufacture of Feraheme, including information related to pre-clinical safety of PSC and the manufacturing processes and controls related to the incorporation of PSC.
AMAG and its commercial partner for the region, Takeda Canada, have 90 days to respond to the NON.
AMAG Pharmaceuticals chief medical officer Lee Allen said they are working diligently with Takeda Canada to ensure that every issue raised in the NON is addressed.
Feraheme received marketing approval from the US Food and Drug Administration on 30 June 2009 and was commercially launched by AMAG in the US shortly thereafter.