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news.Solvay Pharmaceuticals has reported that the FDA has granted fast track designation to the development program for levodopa or carbidopa intestinal gel, for the potential long-term treatment of motor fluctuations associated with advanced Parkinson's disease.
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Fast track is a process designed to facilitate the development and expedite the review of drugs that treat serious diseases and fill an unmet medical need. Once a drug receives fast track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process.
Solvay Pharmaceuticals is currently investigating levodopa or carbidopa intestinal gel in a global Phase III open-label safety study and will enroll patients in pivotal studies in the US and Germany in 2008.