Focalin XR 30mg approved for attention deficit hyperactivity disorder (ADHD)

The FDA has approved a higher 30mg dose of Focalin XR (dexmethylphenidate HCl extended-release capsules, from Novartis) for the treatment of attention deficit hyperactivity disorder (ADHD) in patients ≥6 years of age. This approval was based on a summary of clinical safety and efficacy data that included four pediatric studies, one adult study, and two studies with healthy volunteers. Study data demonstrated Focalin XR to be efficacious at doses of 30mg/day in children, and 30mg/day and 40mg/day in adults compared with placebo. Improvement in ADHD symptoms was shown to be statistically significant for up to 12 hours compared with the placebo.

Focalin XR is already available in 5mg, 10mg, 15g, and 20mg dosage strengths.

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