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GSK/Xenoport's restless legs drug Solzira delayed in US by REMS
10 November 2009
Asher Mullard

asher.mullard@informa.com

The US FDA has delayed the PDUFA date for GlaxoSmithKline/ Xenoport's Solzira (gabapentin enacarbil extended-release; previously known as GSK1838262) tablets by three months to review a risk evaluation and mitigation strategy (REMS) that has been added to the submission package. The drug's new PDUFA...



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