AMAG Updates Feraheme Label To Include Safety Risks

Law360, New York (November 30, 2010, 5:32 PM EST) -- AMAG Pharmaceuticals Inc. has reached an agreement with the U.S. Food and Drug Administration to update the label for its injectable iron deficiency treatment Feraheme to include adverse reactions identified after the drug gained market approval.

The FDA signed off on AMAG's new product label for Feraheme on Nov. 24, AMAG said Monday.

Feraheme, AMAG's brand name for ferumoxytol, is an injection used to treat anemia in patients with chronic kidney disease. The company had been negotiating with the FDA over safety concerns in the wake...
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