Cephalon Provigil “approvable”
Executive Summary
Cephalon's Provigil "approvable," Oct. 20 FDA letter says. Provigil (modafinil) is approvable for improving wakefulness in patients with excessive sleepiness associated with shift work sleep disorder and in patients with obstructive sleep apnea/hypopnea syndrome, in-line with FDA advisory committee recommendation (1"The Pink Sheet" Sept. 29, 2003, p. 25). Cephalon expects to launch the product in February...
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