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Complete Response From FDA Leaves AMAG Iron Product’s Launch Still On Target

This article was originally published in The Pink Sheet Daily

Executive Summary

Company plans no new ferumoxytol trials.

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FDA decision on AMAG’s iron therapy ferumoxytol is also key event for small-cap biotech this year.

Gilead, Myriad Top J.P. Morgan’s 2009 Short List

FDA decision on AMAG’s iron therapy ferumoxytol is also key event for small-cap biotech this year.

AMAG’s ferumoxytol gets Dec. 30 PDUFA date

AMAG hopes to ring in the new year with approval of its anemia product ferumoxytol, recently assigned a Dec. 30, 2008 PDUFA target action date. FDA designated the company's resubmission to an October "complete response" letter as a complete Class 1 response, setting a two month review clock, the firm announced Nov. 13. Ferumoxytol, an intravenous iron replacement agent, is indicated for treatment of iron deficiency anemia in patients with all stages of chronic kidney disease, as well as a diagnostic agent for vascular-enhanced magnetic resonance imaging to assess peripheral arterial disease. AMAG aims to launch the drug, which provides quicker administration at higher doses than available I.V. iron products, in the first quarter of next year (1"The Pink Sheet" DAILY, Oct. 20, 2008). A potential rival, Luitpold's Injectafer, has two "not approvable" letters to its name, including one requesting more clinical trials

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