1.0Public Citizenhttps://www.citizen.orgDiane Krauthamerhttps://www.citizen.org/author/dkrauthamer/Letter to FDA Opposing Approval of Deferiprone - Public Citizenrich600338<blockquote class="wp-embedded-content" data-secret="j1gyNMluCi"><a href="https://www.citizen.org/article/letter-to-fda-opposing-approval-of-deferiprone/">Letter to FDA Opposing Approval of Deferiprone</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://www.citizen.org/article/letter-to-fda-opposing-approval-of-deferiprone/embed/#?secret=j1gyNMluCi" width="600" height="338" title="“Letter to FDA Opposing Approval of Deferiprone” — Public Citizen" data-secret="j1gyNMluCi" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script type="text/javascript">
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We strongly oppose FDA approval of ApoPharma’s NDA for deferiprone for treatment of patients with transfusional iron overload when current chelation therapy is inadequate because the data presented by the sponsor in support of the NDA were grossly insufficient and fail to demonstrate that deferiprone is safe and effective in the intended patient population (i.e., any patient with transfusional iron overload), even under the standards permitted under FDA regulations at 21 C.F.R. Part 314, Subpart H (“Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses”).https://www.citizen.org/wp-content/uploads/public_citizen_shared_link.jpg1200628