Noven MethyPatch submission
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA accepts Noven's June 27 NDA for MethyPatch, a once-daily methylphenidate patch for attention deficit disorder. The NDA, which was previously delayed by "unsuccessful" elements of a Phase III trial, contains two Phase III studies, including a trial in 200 six to 12 year olds showing a statistically significant improvement in attention and behavior versus placebo (Pharmaceutical Approvals Monthly, May 2002, p. 28