FDA delays approval of Requip in extended release form

LONDON The Food and Drug Administration has delayed the approval of an extended release version of the GlaxoSmithKline Parkinson’s disease drug, Requip, according to published reports.

The FDA, though, did offer the company a conditional approval, which means that the agency requires certain conditions be satisfied before the drug can obtain final marketing approval. Those conditions though were not released publicly.

Requip XL, would be a once-daily formation of Requip, which is usually taken three times daily. According to drugpatentwatch.com, Requip had sales of over $260 million in the U.S. in 2006.

Currently, Requip XL has been approved in eight European countries, and is expected to be launched in an additional 17 markets by the first quarter of 2008.