UCB SA (UCB) announced that it has received a complete response letter from the U.S. Food and Drug Administration or FDA, recommending reformulation of Neupro before making it available in the U.S. market for the treatment of Parkinson's disease and restless legs syndrome.
FDA's response is to an NDA Supplement that UCB submitted in June 2009, with a proposal for new refrigerated storage conditions to alleviate crystallization on the patches.
More than 50 thousand patients are being treated by Neupro in Europe. In the U.S., a Patient Access Program is ongoing and UCB will continue this program.
About Neupro in Europe Neupro is approved in the European Union for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease, as monotherapy or in combination with levodopa.
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