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US clears Amgen's Nplate with restricted distribution scheme

This article was originally published in Scrip

Executive Summary

The US FDAhas required a restricted distribution programme and mandatory postmarketing studies for Amgen's novel thrombopoietin receptor agonist Nplate (romiplostim). The agency approved Nplate on August 22nd for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP) in patients who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.



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