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GSK Faces Another Delay on Requip Decision
The FDA has extended until the second quarter of this year the action date for GlaxoSmithKline’s (GSK) Requip XL extended-release tablets, which are indicated to treat the signs and symptoms of idiopathic Parkinson’s disease. The action is the second recent delay in the Requip (ropinirole HCl) approval process for the Parkinson’s indication. GSK had to submit additional information on the food effect of the drug following the receipt of an approvable letter in December 2007. Requip XL uses UK drugmaker SkyePharma’s Geomatrix technology to provide a steady rate of absorption in the body to help reduce daily blood plasma fluctuations. It was approved last year in France, Slovakia, Slovenia, Latvia, Estonia and Canada. Requip is approved for moderate to severe restless leg syndrome. |
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