Solzira NDA resubmitted
GlaxoSmithKline and XenoPort resubmit their NDA for Solzira (gabapentin enacarbil) for the treatment of restless leg syndrome Jan. 9. GSK withdrew the application last November when FDA requested that data in a single study be reformatted (1"The Pink Sheet" DAILY, Nov. 10, 2008). In addition to reformatting the data, GSK also conducted a review of other clinical studies, and the filing now consists of three Phase III trials
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Filing’s content is unaffected, says GlaxoSmithKline, which withdrew the recently submitted NDA but will resubmit it “as quickly as possible.”
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