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