FDA Grants Full Approval for PROMACTA(R) (eltrombopag) for Treatment of Rare Blood Disorder

New label includes six-month efficacy and two-year safety data PHILADELPHIA, Feb. 25, 2011 /PRNewswire via COMTEX News Network/ -- GlaxoSmithKline (NYSE: GSK) today announced that the United States Food and Drug Administration (FDA) granted full approval for PROMACTA(R) (eltrombopag), an oral tablet that can raise platelet counts in patients with the rare blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. PROMACTA initially received FDA orphan drug designation in May 2008 and accelerated approval in November 2008 for chronic ITP. The FDA Accelerated Approval program offers a...

Source:
http://article.wn.com/view/2011/02/25/FDA_Grants_Full_Approval_for_PROMACTAR_eltrombopag_for_Treat/

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