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Schwarz files Parkinson’s patch

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Schwarz' Sept. 29 submission of Neupro (rotigotine) for treatment of early-stage Parkinson's disease is the generic firm's first attempt at the new drug market. The transdermal rotigotine patch is "the first submission of a novel new chemical entity from our…pipeline," the company says. Rotigotine is a non-ergot dopamine D2 agonist; Schwarz licensed the product from Aderis in 1998. Phase III studies in late-stage PD are ongoing, with an NDA projected for first-quarter 2006. A nasal spray rotigotine formulation is in Phase I studies for acute PD...
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