FDA denies approval for AMAG’s Feraheme

12/23/2008

LEXINGTON, Mass. The Food and Drug Administration has delivered a complete response letter to AMAG Pharmaceuticals for a drug for treating anemia in kidney disease patients, AMAG announced Monday.

The FDA said it will not approve the drug Feraheme (ferumoxytol) until it receives data to clarify a specific chemistry, manufacturing and controls issue; resolution of deficiencies observed during the pre-approval inspection of AMAG?s factory; and finalization of labeling discussions with the FDA.

“We will continue to work expeditiously and collaboratively with the FDA to address the issues raised in the complete response letter,” AMAG president and CEO Brian Pereira said. “We are pleased with the progress that we have made in addressing the observations raised during the pre-approval inspection of our manufacturing facility, and we are fully committed to conducting our manufacturing operations consistent with the highest quality standards.”

AMAG originally submitted its approval application for Feraheme in December 2007 and received a complete response letter in October of this year.

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