Food
and Drug Administration
Center for
Drug Evaluation and Research (CDER)
Chair
Introduction of Committee
Conflict of Interest Statement Anuja M. Patel, M.P.H.
On
September 25, the committee will discuss supplementary new drug application
(SNDA 20-717 /S-008) Provigil (modafinil) Tablets,
Cephalon, Inc., indicated for use to improve wakefulness in patients with excessive sleepiness associated with
disorders of sleep and wakefulness.
Overview of Issues
· Introduction
· Review of Excessive
Sleepiness
· Overview of Efficacy and
Safety
Break