FDA delays Requip XL approval
The FDA has delayed approval of GlaxoSmithKline and SkyePharma's reformulated Requip XL (ropinirole) as a treatment for Parkinson's disease.
The agency deferred its decision on the drug after makers were asked to submit additional information on the food effects of Requip XL last month.
A decision on the drug, initially due in the first quarter of 2008, is now not expected until the second quarter. Initial filing for Requip XL took place in April 2007.
Requip XL is already approved to treat Parkinson's in 13 European countries.