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).