Advertisement

Health Canada has stalled a new drug submission from AMAG Pharmaceuticals Inc. with a notice of non-compliance for its Feraheme injection, intended to treat iron deficiency anemia in adult chronic kidney disease patients. The treatment was subjected to scrutiny in the U.S. – and a demand for new warning labels – by the FDA in 2010 following reports of life-threatening hypersensitivity to the drug and instances of significant low blood pressure.

Lexington-based AMAG and Takeda Canada Inc., its commercial partner, have 90 days to respond to the notice.

SOURCE

SOURCE

Advertisement
Advertisement