Schwarz Neupro "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Schwarz' early-stage Parkinson's treatment Neupro (rotigotine transdermal system) is "approvable" pending submission of "additional analyses and summaries from the existing database," the firm announces March 1. "We anticipate responding to the action letter within six months," the company says. FDA's decision on the new molecular entity comes after the agency extended its user fee date by 90 days (1Pharmaceutical Approvals Monthly December 2005, p. 5). Schwarz plans to submit an sNDA for advanced Parkinson's by the end of 2006; Phase III results in restless legs syndrome are expected in the first quarter of 2007...
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