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FDA approves REMS for Nuvigil, Provigil
FRAZER, Pa. The Food and Drug Administration has approved risk evaluation and mitigation strategies for two sleep disorder drugs made by Cephalon, the drug maker said.
Cephalon announced that the FDA approved the REMS for Nuvigil (armodafinil) and Provigil (modafinil), both used to improve wakefulness in patients with sleep apnea, narcolepsy or shift work disorder.