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Nplate Approval History

Nplate (romiplostim) is a thrombopoietin mimetic peptibody for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).

Development History and FDA Approval Process for Nplate

DateArticle
Aug 22, 2008Approval FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP
Jul 15, 2008Amgen's FDA Nplate Approval Statement Retracted
Jul 14, 2008FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP
Mar 13, 2008Amgen Statement on Successful Outcome of Romiplostim Panel Meeting
Mar 12, 2008Amgen to Discuss Romiplostim Application at FDA ODAC Meeting

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