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February 6, 2008 |
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SKYEPHARMA PLC: U.S. FDA Extends Review Period for Requip XLTM SkyePharma PLC has been informed that the United States Food and Drug Administration has extended the Prescription Drug User Fee Act action date for GlaxoSmithKline's Requip(R) XLTM Extended Release tablets. The PDUFA action date is the date by which the FDA is expected to issue a response on a pending new drug application. Following the approvable letter for Requip XL issued in December 2007, GlaxoSmithKline submitted a response to the FDA. A final decision from the FDA had been expected in Q1 2008. However, GSK has recently submitted additional information on food effect to the FDA. The agency has determined that they would not have sufficient time to review this information prior to the Q1 action date and the final decision is now expected to be received in Q2 2008. Requip(R) XLTM is the first and only once-daily oral non-ergot dopamine agonist indicated to treat the signs and symptoms of idiopathic Parkinson's disease. It uses SkyePharma's patented GEOMATRIXTM technology and has been designed to provide a steady rate of absorption in the body to help reduce daily blood plasma fluctuations. The product is expected to be available in pharmacies shortly after the anticipated approval. SkyePharma is pleased to note the launch in France last week of Requip(R) LP Extended Release tablets (as Requip(R) XLTM Extended Release tablets are known in France). Headquartered in London, SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) -- http://www.skyepharma.com/ -- develops pharmaceutical products benefiting from world-leading drug delivery technologies that provide easier-to-use and more effective drug formulations. There are now 12 approved products incorporating SkyePharma's technologies in the areas of oral, injectable, inhaled, and topical delivery supported by advanced solubilization capabilities. The Group balance sheet as at June 30, 2007, shows GBP55.1 million in total shareholders' deficit. |
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