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AMAG iron replacement drug's Canadian approval stalled

Wed, 02/09/2011 - 8:38pm
Mass High Tech: The Journal of New England Technology

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.

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