Novartis Pharmaceuticals announced this morning that the FDA has approved new labeling for Focalin XR (dexmethylphenidate HCl), an extended-release stimulant medication aimed at treating attention deficit hyperactivity disorder (ADHD).
The main differentiator for the new labeling is Focalin XR's 30-minute onset, which Novartis reps say will help with early morning struggles, such as getting ready for school.
The company gained the FDA approval after providing clinical study data showing improvements in attention, deportment and academic productivity in children between the ages of six and 12. The most recent study involved 86 children.
- read the story at RTT News