www.fdanews.com/articles/197274-fda-approves-chiesi-groups-ferriprox-twice-a-day-tablets
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FDA Approves Chiesi Group’s Ferriprox Twice-A-Day Tablets
May 26, 2020
The FDA has approved Chiesi Group’s Ferriprox (deferiprone) twice-a-day tablets for transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.
The new formulation of twice-a-day Ferriprox 1000mg tablets eliminates the midday dose and allows patients to take it once in the morning and in the evening.
The approval of the twice-daily doses was based on a reduction in serum ferritin levels, as there were no controlled trials demonstrating a direct treatment benefit, such as improvement in disease-related symptoms or increased survival.