•Has modafinil been shown to be effective for the
treatment of attention deficit
hyperactivity disorder (ADHD) in children and adolescents?
•Has modafinil been shown to be acceptably safe in the
treatment of attention
deficit hyperactivity disorder (ADHD) in children and adolescents?
•If modafinil were to be considered for approval:
–What kind of a risk management plan should be
implemented with regard to
the signal for serious skin rashes with this drug in the ADHD program?
–How should the concern about serious skin rashes be
addressed in product
labeling (you have been provided our labeling proposal in the approvable letter and also the sponsor’s currently
–Should there be a requirement for a post-marketing
study(ies) to better
understand the serious skin rashes, and what type of study(ies) might be considered?