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Luitpold hoping for third time lucky as Injectafer resubmitted in US

This article was originally published in Scrip

Executive Summary

More than three years after the US FDA issued a second non-approvable letter for the product over safety concerns, Daiichi Sankyo's US subsidiary Luitpold Pharmaceuticals has resubmitted an NDA for its intravenously injected iron preparation Injectafer (ferric carboxymaltose).



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