FDA delays action date for Requip XL
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA needs additional time to review GlaxoSmithKline's newly submitted data on Parkinson's disease candidate Requip XL (ropinirole extended-release), pushing the user fee date back into the second quarter. GSK submitted data after receiving an "approvable" letter concerning proposed labeling and expected a decision in the first quarter. The firm hopes to switch patients to the extended-release formulation, which is already approved in immediate-release form for Parkinson's and restless legs syndrome, ahead of anticipated generic competition in May...