U.S. FDA Issues Approvable Letter for Requip XL Extended Release Tablets
 

U.S. FDA Issues Approvable Letter for Requip XL Extended Release Tablets

LONDON, UK, 10 December 2007-- SkyePharma PLC (LSE: SKP) today announces that the United States Food and Drug Administration (FDA) has issued an approvable letter for GlaxoSmithKline's (NYSE:GSK) Requip(R) XL(TM) Extended Release
http://www.engelpub.com/News/index.cfm?articleid=498870

tablets. An approvable letter is an official notification from the FDA that contains conditions that must be satisfied prior to obtaining final U.S.
marketing approval.

Requip(R) XL(TM) is a once-daily oral dopamine agonist developed for the treatment of the signs and symptoms of idiopathic Parkinson's disease. The new Requip(R) XL(TM) formulation uses SkyePharma's patented GEOMATRIX(TM) technology and is designed to provide a steady rate of absorption in the body to help reduce daily blood plasma fluctuations. GSK is committed to working with the FDA to address any questions they have and evaluate the best way forward.

Requip(R) XL(TM) is approved in eight countries in Europe and a mutual recognition procedure was successfully completed on 27 November 2007, in 17 additional European countries. This step should result in approval of Requip(R) XL(TM) and launches in these countries from the first quarter of 2008 onwards.