ROCKVILLE, Md. -- Shire Pharmaceuticals Group plc announced that it has received an 'approvable' letter from the US Food and Drug Administration (FDA) for ADDERALL XR(R) once daily treatment for adult Attention Deficit Hyperactivity Disorder (ADHD). The Supplemental New Drug Application (sNDA), which was submitted to the FDA on 18 December 2002, included a comprehensive clinical programme in adult patients. The adult market is roughly twice the size of the pediatric market(2). Approximately 66%(2) of children with ADHD will continue to suffer from the disease throughout their adult life.
Posted by Editor at October 20, 2003 10:36 AM