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GSK Resubmits Solzira NDA

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By: Tim Wright

Editor-in-Chief, Contract Pharma

GlaxoSmithKline and development partner XenoPort have resubmitted the NDA to the FDA requesting approval of Solzira Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
 
The FDA requested that the data in one study be reformatted. GSK also included recent data from other clinical studies. The withdrawal was not related to the content of the filing.

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