Methypatch advisory committee review

Executive Summary

Shire/Noven's methylphenidate patch, Methypatch, for attention deficit/hyperactivity disorder in children ages six to 12 will be reviewed by FDA's Psychopharmacologic Drugs Advisory Committee Dec. 2. Noven received a "not approvable" letter for its original application in April 2003 based on concerns over dosing, duration of wear and incidence of side effects. In June, the advisory committee recommended against adding warnings regarding psychiatric events to methylphenidate product labeling based on data that showed no new signal (1"The Pink Sheet" July 4, 2005, p. 3). The meeting will be held at the Hilton in Gaithersburg, Md...