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FDA Trial Design Challenge: Does Same Indication Demand Same Kind Of Study?

Executive Summary

Luitpold citizen petition seeking to block AMAG’s expanded indication for injectable iron offers FDA an opportunity to weigh in on how similar trial designs must be for drugs with the same indication.

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AMAG’s Turnaround Plans Hit A Snag With Feraheme CRL

FDA declined to approve the I.V. iron in a broad patient population and requested another clinical trial to further evaluate safety. The decision gives rival Daiichi more time to penetrate the market with its I.V. iron Injectafer.

AMAG’s Feraheme Expansion Strategy Delayed For Now

FDA has extended by three months its review of a sNDA for the I.V. iron product that would expand the drug’s use into a far broader patient population.

Luitpold Citizen Petition May Handicap AMAG’s Ferumoxytol

A citizen petition filed by AMAG rival Luitpold stressing the dangers of intravenous iron therapy - an area with well-known hazards - seems designed to handicap AMAG's nanoparticle agent ferumoxytol, which bears a PDUFA date of Oct. 19

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