Corrected: FDA pushes back review of GlaxoSmithKline treatment for restless leg syndrome
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Editor's note: XenoPort issued a correction to a press release issued last Friday about the FDA delay in review of a proposed drug. Rather than a treatment for shingles, XenoPort said the drug involved is for restless leg syndrome.
"The NDA currently under review by the FDA is for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). The original PDUFA date for this NDA review was November 9, 2009," XenoPort said.
RESEARCH TRIANGLE PARK, N.C. – The U.S. Food and Drug Administration has pushed back its delay of a proposed treatment for restless leg syndrome that is being developed by GlaxoSmithKline (NYSE: GSK) and California-based XenoPort.
The companies announced the FDA’s decision after markets closed on Friday.
The FDA had been expected to announce a decision on the new drug application filed by GSK and XenoPort on Nov. 9. Instead, the FDA requested additional data and pushed back the review date to Feb. 9, 2010.
GSK maintains its U.S. headquarters in RTP and employs some 4,000 people in the area.
Copyright 2010 Local Tech Wire. All rights reserved.
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