AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that it 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 for the treatment of iron deficiency anemia in adult chronic kidney disease patients. AMAG and its commercial partner for the region, Takeda Canada Inc., have 90 days to respond to the NON.
“We are working diligently with Takeda Canada to ensure that every issue raised in the NON is addressed”
The NON outlined Health Canada's concerns, which are focused mainly on chemistry, manufacturing, and control (CMC) and preclinical toxicology issues. Among other things, 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.
"We are working diligently with Takeda Canada to ensure that every issue raised in the NON is addressed," said Lee F. Allen, MD, PhD, Chief Medical Officer of AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc.