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Novartis Exjade Clears FDA As First Oral Chelating Agent

This article was originally published in The Pink Sheet Daily

Executive Summary

Novartis receives broad indication for deferasirox for treatment of iron overload in patients over 2 years of age.

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FDA's Oct. 14 accelerated approval of ApoPharma's second-line oral iron chelation therapy Ferriprox (deferiprone) includes a requirement that the sponsor conduct a post-marketing QT prolongation study, which the agency did not mention in background documents before the key advisory panel vote.

ApoPharma's Ferriprox Clears FDA, But Needs Cardiac Safety Study

FDA's Oct. 14 accelerated approval of ApoPharma's second-line oral iron chelation therapy Ferriprox (deferiprone) includes a requirement that the sponsor conduct a post-marketing QT prolongation study, which the agency did not mention in background documents before the key advisory panel vote.

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