Committee endorses Daytrana

An FDA advisory committee voted unanimously Friday that Daytrana methylphenidate transdermal system (MTS) from Shire (LSE:SHP; SHPGY) and Noven (NOVN) is safe and effective to treat pediatric ADHD.

The vote followed a briefing from Robert Levin, FDA's lead medical reviewer for Daytrana, who reversed his previous recommendation against approving the product (see BioCentury Extra, Thursday Dec. 1, 2005). Levin said that he initially was concerned that there was a higher incidence of some adverse effects in patients exposed to Daytrana compared with those who took Concerta from Johnson & Johnson (JNJ). Upon further reflection, he determined that the differences were not statistically significant or sufficiently large to tip the risk-benefit balance against approval. ...