U.S. FDA Extends Review Period for Requip XLTM Extended Release Tablets
LONDON, UK, 5 February 2008-- SkyePharma PLC (LSE: SKP) has been informed that the United States Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) action date for GlaxoSmithKline's (NYSE: GSK) Requip(R) XLTM Extended Release tablets.Â The PDUFA action date is the date by which the FDA is expected to issue a response on a pending new drug application.Â Following the approvable letter for Requip XL issued in December 2007, GlaxoSmithKline submitted a response to the FDA.Â A final decision from the FDA had been expected in Q1 2008.Â 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.Â 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.Â The product is expected to be available in pharmacies shortly after the anticipated approval.
SkyePharma PLC 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).
About SkyePharma PLC
Using its proprietary drug delivery technologies, SkyePharma develops new formulations of known molecules to provide a clinical advantage and life-cycle extension. The Company has twelve approved products in the areas of oral, inhalation and topical delivery.Â The Group's products are marketed throughout the world by leading pharmaceutical companies.
For more information, visit www.skyepharma.com
Ropinirole Extended-Release Tablets have been approved in 13 European countries and are marketed by GlaxoSmithKline under the brand names Requip XL, Requip Modutab, Requip LP and Requip Depot. GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies. More information on GlaxoSmithKline is available at the company's website at www.gsk.com.