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News Archive
Solvay's Duodopa Intestinal Gel Gets FDA Fast Track Status for Parkinson's
Feb 20 2008
Solvay SA said the US Food and Drug Administration has granted fast track designation for Duodopa, the levodopa/carbidopa intestinal gel it is developing for the long-term treatment of motor fluctuations associated with advanced Parkinson's disease.
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. The company said that most drugs are eligible for fast track designation also receive a priority review. The goal for completing a priority review is six months.
In 2000, levodopa/carbidopa intestinal gel received orphan drug designation from the FDA for the treatment of late-stage Parkinson's disease.
The drug is currently in a Phase III worldwide study and Solvay will enroll patients in pivotal studies in the US and Germany this summer, it said.
Source Publication: Thomson Financial
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