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U.S Recommends Reformulation of UCB's Neupro
- Apr 23 2010
- Says U.S. regulator FDA recommends reformulation
- Estimates will take two years to reformulate Neupro
- Says does not affect availability outside the U.S.
BRUSSELS, April 23 (Reuters) - Belgian pharmaceutical group UCB <UCB.BR> said on Friday the U.S. relaunch of its Parkinson's patch Neupro could be delayed by two years after U.S. regulators recommended reformulation of the drug.
Neupro, which is approved in the European Union for the early treatment of Parkinson's disease, was removed from the U.S. market in 2008 because crystals had developed in some patches.
UCB has been in talks with the U.S. Federal Drug Administration (FDA) about reintroducing the Parkinson's disease patch.
The group estimated it would take two years to reformulate Neupro, meaning it would not be able to resubmit the drug for FDA approval before 2012.
The FDA decision did not impact product supply and availability in Europe and the rest of the world, UCB said. (Reporting by Antonia van de Velde; Editing by David Holmes)