Shire, plc, has announced that it is withdrawing its European Marketing Authorization Application (MAA) for Daytrana®, an ADHD medication. Daytrana® is a patch, developed for children ages six to 12, that releases a steady, low dose of ADHD medication for up to 9 hours.

"Shire stated that its decision to withdraw the MAA was based on the fact that European regulatory authorities had requested an addiction clinical study for Daytrana® in a European patient population, and that Shire planned to enter the European ADHD market through the previously-announced acquisition of a... product that is already approved in Europe."

Shire will continue to market Daytrana® in the United States, where it has already been subjected to clinical tests and approved. Source: BusinessWire

Labels: medications, treatment, patch

Posted By: Aspen Education Group