UCB Receives Complete Response Letter from U.S. FDA Regarding Neupro (Rotigotine)
UCB announced that the U.S. food and Drug Administration (FDA) has provided a complete response letter recommending reformulation of Neupro® (Rotigotine Transdermal System) before making it available in the U.S. market for the treatment of Parkinson's disease (PD) and restless legs syndrome (RLS). 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.
"FDA agrees that the proposed new refrigeration conditions significantly inhibit the degree of crystallization on the patches, but has recommended that the definitive resolution of the crystallization is to reformulate the drug product," said Prof. Dr. Iris Loew-Friedrich, Executive Vice President and Chief Medical Officer of UCB. "This FDA decision does not impact product supply and availability in Europe and the rest of the world. It does not change previous assessments made by the European and other international authorities regarding the cold chain storage process."
More than 50 000 patients are being treated by Neupro® in Europe. In the U.S., a Patient Access Program is ongoing and UCB will continue this program.
Other news from the department research and development
