GSK update on FDA review of PromactaŽ (eltrombopag)
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GlaxoSmithKline today announced that the United States Food and Drug Administration (FDA) has extended the priority review period for PromactaŽ (eltrombopag) for the short-term treatment of previously treated patients with chronic idiopathic thrombocytopenic purpura, as they require more time to review the application. The Prescription Drug User Fee action date has been extended to 19 September 2008.
On 30 May, the Oncology Drugs Advisory Committee unanimously voted, 16-0, that eltrombopag demonstrated a favourable risk-benefit profile for the short-term treatment of patients with chronic idiopathic thrombocytopenic purpura, or ITP.
GSK will continue to work with the FDA towards the approval of eltrombopag in order to provide physicians and chronic ITP patients with a novel option for treating this difficult disease.
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